Icatibant
Also sold as: Firazyr, icatibant acetate, HOE 140, JE049
Icatibant is an FDA-approved drug: FDA approved Firazyr (icatibant) injection under NDA 022150 on 25 August 2011, and the approved labeling indicates it 'for the treatment of acute attacks of hereditary angioedema (HAE) in adults 18 years of age and older' — acute attacks rather than prophylaxis, and adults only, with safety and effectiveness in patients below 18 years not established. Approval came on the second cycle: FDA took a Not Approval action on the original application in April 2008 because substantial evidence of efficacy was not demonstrated in the two pivotal studies, and the placebo-controlled trial of that pair, FAST-1, did not meet its prespecified primary endpoint; a third trial, FAST-3, showed icatibant statistically superior to placebo and carried the approval. That approval does not reach angioedema induced by ACE inhibitors — the FIRAZYR label states that clinical trials to date have excluded subjects taking ACE inhibitors, and in a later Phase 3 randomised placebo-controlled trial of 121 subjects the investigators reported no difference between icatibant and placebo in time to meeting discharge criteria. Six generic icatibant injection products are also approved, and icatibant appears in none of the three categories of FDA's 503A bulk drug substances list.
Which molecule this is. A synthetic decapeptide, described in the FDA-approved labeling as containing five non-proteinogenic amino acids. Its pharmacological class per the label is bradykinin B2 receptor ANTAGONIST — it blocks a receptor rather than stimulating one, which is the opposite of the growth-factor and secretagogue peptides most of this site covers. The approved products contain the ACETATE SALT: FDA's product records list the active ingredient as icatibant acetate, with strength expressed as icatibant free-base equivalent. Unlike the semaglutide case, the salt is what is approved, not a substitute for it.
FDA status
FDA has approved this as a drug. Approval is always for a specific indication and a specific population — check which one, because it is frequently not the use it is marketed for.
FDA-approved and marketed. Approval is always for a specific indication and population, and here it is narrow — see the approval record below. STILL CURRENT, checked rather than assumed: Drugs@FDA (openFDA `drug/drugsfda`, dataset last updated 2026-07-31) returns seven applications whose active ingredient is icatibant acetate — NDA 022150 (FIRAZYR, Takeda Pharmaceuticals U.S.A.) plus six ANDAs — and every one of the seven carries marketing status 'Prescription' rather than 'Discontinued'. Sponsorship moved over the product's life: the NDA was filed by Jerini, approved to Shire Orphan Therapies in 2011, and is held by Takeda today. Same application number throughout.
“This new drug application provides for the use of Firazyr (icatibant) Injection for the treatment of acute attacks of hereditary angioedema in adults 18 years of age and older. We have completed our review of this application, as amended. It is approved, effective on the date of this letter, for use as recommended in the enclosed agreed-upon labeling text.”Checked against the source on .
Evidence
Efficacy established by adequate, well-controlled trials in humans.
Administration check RUN, not assumed, and the trials are named rather than counted. FDA's Summary Review identifies three pivotal Phase 3 studies by internal number — 2103 (FAST-1), 2102 (FAST-2) and 054 (FAST-3) — and each was matched to its registration by PROTOCOL NUMBER rather than by name, because the label names no registrations: NCT00097695 carries org study ID 'JE049 #2103' (FAST-1, 84 enrolled ACTUAL, icatibant versus placebo), NCT00500656 carries 'JE049 #2102' (FAST-2, 85 ACTUAL, icatibant versus oral tranexamic acid), and NCT00912093 carries 'HGT-FIR-054' and names FAST-3 in its own brief title (98 ACTUAL, icatibant versus placebo). All three were opened on 2026-08-02: lead sponsor Shire, Phase 3, status COMPLETED, hasResults true, intervention type DRUG. Icatibant was ADMINISTERED subcutaneously to patients during acute attacks; it was not measured as an endogenous biomarker, which is the trap that reduces MOTS-c and TB-500 from an apparent five human RCTs to an actual zero. THE TIER IS NOT UNANIMOUS ACROSS THOSE TRIALS, and the record says so. FAST-1, the first placebo-controlled trial, MISSED its prespecified primary endpoint (p = 0.142 versus placebo, per FDA's own table), and FDA refused the original application in April 2008 on that basis. Approval rests on FAST-3, a second placebo-controlled trial that met a REDEFINED primary endpoint, plus FAST-3's key secondary endpoint, which was the endpoint FAST-1 had failed. Both of those are recorded below with their own sources. SCOPE — the tier attaches to the treatment of acute attacks of hereditary angioedema in adults, and to nothing else. It does not extend to routine prophylaxis, to patients under 18, or to angioedema induced by ACE inhibitors, where the Phase 3 trial that tested this exact molecule reported no difference from placebo.
“The additional study, FAST-3, which used a placebo control, showed that icatibant was statistically superior to placebo on the prespecified efficacy endpoint of 3-symptom composite VAS (Table 3).”Checked against the source on .
What FDA actually approved
- Application
- NDA 022150 — Firazyr
- Approved indication
- FIRAZYR® (icatibant) is indicated for the treatment of acute attacks of hereditary angioedema (HAE) in adults 18 years of age and older.
One sentence, and every clause in it is a limit. (1) 'ACUTE ATTACKS' — this is rescue treatment for an attack in progress, not routine prophylaxis to prevent attacks. Other approved products carry prophylaxis indications; this one does not. (2) 'HEREDITARY angioedema' — the indication is confined to the inherited C1-inhibitor disorder. Bradykinin-mediated angioedema from other causes is outside it, most consequentially the ACE-inhibitor-induced form, which is recorded separately below. (3) 'in ADULTS 18 YEARS OF AGE AND OLDER' — the label states in section 8.4 that safety and effectiveness in patients below 18 have not been established. `discontinued` is false: FDA's product record for NDA 022150 carries marketing status 'Prescription'. Note that the six approved generics are approved against this same labeling — an ANDA does not widen an indication.
“FIRAZYR® (icatibant) is indicated for the treatment of acute attacks of hereditary angioedema (HAE) in adults 18 years of age and older.”Checked against the source on .
What FDA found
FDA’s own words. These are the most citable thing on this site, and the least likely to appear anywhere funded by someone selling the compound.
FDA took a Not Approval action on the original icatibant application in April 2008, because substantial evidence of efficacy was not demonstrated in the two pivotal studies submitted with it. Approval followed only after a third controlled study.
Independently corroborated inside the approval letter, which refers to FDA's 'April 23, 2008, action letter' and records that the February 25, 2011 submission 'constituted a complete response' to it. Two FDA documents, same fact. This matters beyond history. An approved drug is routinely described as though its evidence arrived clean; here FDA is on record that it did not, and the reason is methodological rather than pharmacological — a failed placebo comparison and an active comparator FDA did not accept.
Summary Review of Regulatory Action — NDA 22-150, Firazyr (icatibant) — FDA, 24 August 2011“The original NDA was submitted in October 2007, and a Not Approval action was taken in April 2008, because substantial evidence of efficacy was not demonstrated in two pivotal studies. The original NDA included one placebo-controlled study that did not show efficacy, and another tranexamic acid (TA) active-controlled study that showed efficacy.”
Checked against the source on .On the prespecified primary endpoint of the two original pivotal trials, FDA reported that icatibant was statistically superior to tranexamic acid in FAST-2 but NOT to placebo in FAST-1. FDA's table records p = 0.142 for FAST-1 against placebo for all attacks, with cutaneous and abdominal attacks at p = 0.221 and p = 0.159.
Recorded because a positive result on a redefined endpoint is not the same thing as a positive result, and the difference is invisible from the label. FDA is explicit that FAST-3 used a DIFFERENT definition of symptom relief from FAST-1 and FAST-2, that a post-hoc reanalysis of FAST-1 under FAST-3's endpoint did reach significance (p = 0.014), and that these are 'post hoc analyses'. FDA also flagged that blinding may have been imperfect — icatibant produces injection site reactions in almost all patients — writing that 'there is no assurance that the blinding succeeded' and that the confounding influence 'cannot be completely ruled out'. FDA's own resolution of that concern was FAST-3: 'the additional FAST-3 study showing efficacy in a placebo-controlled study is reassuring of efficacy.'
Summary Review of Regulatory Action — NDA 22-150, Firazyr (icatibant) — FDA, 24 August 2011“Based on the prespecified primary efficacy endpoint of median time to onset of symptom relief as measured by single-symptom VAS, icatibant was statistically superior to TA in FAST-2 study, but not to placebo in FAST-1 study (Table 2). Results of FAST-1 showed numerical trend for icatibant over placebo, but the difference was not statistically significant.”
Checked against the source on .FDA found that tranexamic acid was not a valid active control for acute attacks of hereditary angioedema, and that efficacy shown against it in FAST-2 was not adequate for approval because tranexamic acid is not approved for that use.
The general lesson is bigger than this drug: beating a comparator establishes nothing unless the comparator works. FDA searched the literature and found three studies using tranexamic acid for acute attacks, in 5, 7 and 27 patients respectively, and noted the package insert and literature 'seem to support its use for chronic long-term therapy, but not for acute attacks'. FDA went further and observed that the cross-trial comparison ran the wrong way for the sponsor's expert opinion — tranexamic acid 'performed appreciably worse in one study compared to placebo in the other study'.
Summary Review of Regulatory Action — NDA 22-150, Firazyr (icatibant) — FDA, 24 August 2011“The existing data do not support use of TA as a valid active control. With no data supporting it use, an important question is whether TA could perform worse than placebo.”
Checked against the source on .The FDA-approved labeling states that safety and effectiveness of FIRAZYR in pediatric patients below the age of 18 years have not been established.
Read alongside the label's juvenile animal data, which is why the gap is not merely administrative: the label reports that subcutaneous daily administration to young rats during the juvenile period of development delayed sexual maturation of male reproductive tissues, and that impaired fertility and reproductive performance were also observed in male rats at the end of the postnatal treatment period. The label attributes these to antagonism of the bradykinin B2 receptor and subsequent effects on gonadotropins. Note also what the approval letter records: because the product carried orphan drug designation for this indication, the sponsor was EXEMPT from the pediatric assessment that the Pediatric Research Equity Act would otherwise require.
FIRAZYR (icatibant) Injection, for subcutaneous use — Full Prescribing Information — FDA, 19 January 2024“Safety and effectiveness in pediatric patients below the age of 18 years have not been established.”
Checked against the source on .The FDA-approved labeling states that FIRAZYR, as a bradykinin B2 receptor antagonist, has the potential for a pharmacodynamic interaction with ACE inhibitors and may attenuate their antihypertensive effect, and that clinical trials to date have excluded subjects taking ACE inhibitors.
The most under-read sentence on this label. The single largest off-label use of icatibant is angioedema in patients ON an ACE inhibitor — and the label states that the trials behind the approval excluded exactly those patients. FDA's Summary Review explains the exclusion as clinical practice rather than a safety finding: ACE inhibitors are generally avoided in hereditary angioedema patients because of their own potential to cause angioedema. Either way, the approved evidence base does not contain these patients, and the trial that was later run in them is recorded below.
FIRAZYR (icatibant) Injection, for subcutaneous use — Full Prescribing Information — FDA, 19 January 2024“FIRAZYR is a bradykinin B2 receptor antagonist and thereby has the potential to have a pharmacodynamic interaction with ACE inhibitors where FIRAZYR may attenuate the antihypertensive effect of ACE inhibitors. Clinical trials to date have excluded subjects taking ACE inhibitors.”
Checked against the source on .Icatibant appears in none of Categories 1, 2 or 3 of FDA's 503A bulk drug substances list updated 2026-05-14.
Recorded to close a misreading, not to assert a status — which is why this record carries no compoundingStatus at all. Verified by fetching the document with a browser user-agent and text-extracting it locally on 2026-08-02: zero hits for 'icatibant' across all seven pages. That absence is not BPC-157's absence. BPC-157 was nominated and left Category 2 when its nominators withdrew; icatibant was never in this system, because the 503A bulks list is the route for substances that are neither the subject of a USP monograph nor a component of an approved drug product, and icatibant is a component of seven approved drug products. Categorical silence here is neither permission nor a safety finding.
Bulk Drug Substances Nominated for Use in Compounding Under Section 503A of the Federal Food, Drug, and Cosmetic Act — FDA, 14 May 2026Checked against the source on .Six abbreviated new drug applications for icatibant acetate injection are approved and in prescription marketing status, the first to Teva on 2019-07-15, alongside the originator NDA 022150. All six products carry therapeutic equivalence code AP.
Queried directly against FDA's own API on 2026-08-02; dataset last updated 2026-07-31. The six, by original approval date: Teva ANDA 210118 (2019-07-15), Jiangsu Hansoh ANDA 211021 (2020-03-09), Fresenius Kabi ANDA 208317 (2020-06-18), Cipla ANDA 212446 (2020-07-13), Eugia ANDA 213521 (2023-08-14), Alembic ANDA 213773 (2024-06-14). Two things follow that are easy to get wrong. A generic is approved as therapeutically equivalent to the reference product FOR THE REFERENCE PRODUCT'S INDICATION — the arrival of generics widened availability, not the approved use. And a generic is an approved drug product, not a compounded one: none of this is evidence about compounded or research-labelled material.
Drugs@FDA records for icatibant (openFDA drug/drugsfda API) — FDA, 31 July 2026Checked against the source on .
Documented safety signals
The most commonly reported adverse reactions in the clinical trials were injection site reactions, which occurred in almost all patients (97%). Other common adverse reactions occurring in greater than 1% of patients included pyrexia, transaminase increase, dizziness, and rash.
97% versus 33% on placebo in the two placebo-controlled trials, per the label's Table 1. FDA characterised these reactions in its Summary Review as self-limiting, resolving within a few hours, and 'irritant in nature rather than mediated by specific immune response'. The same near-universal reaction is why FDA doubted the blinding held in the pivotal trials — a signal that is simultaneously a tolerability finding and a methodological one.
FIRAZYR (icatibant) Injection, for subcutaneous use — Full Prescribing Information — FDA, 19 January 2024“The most commonly reported adverse reactions were injection site reactions, which occurred in almost all patients (97%) in clinical trials. Other common adverse reactions occurring in greater than 1% of patients included pyrexia, transaminase increase, dizziness, and rash.”
Checked against the source on .The FDA-approved labeling states that FIRAZYR should be used during acute coronary ischemia, unstable angina pectoris, or in the weeks following a stroke only if the benefit exceeds the theoretical risk to the patient, and that there is limited human experience in acute ischemia.
A mechanism-derived caution, and the most clinically loaded thing on this label. The label reports that icatibant decreased coronary blood flow in the isolated guinea pig heart, aggravated the duration of post-ischemic reperfusion arrhythmias in the isolated rat heart, and that intracoronary infusion in an anesthetized myocardial infarction dog model increased mortality rate two-fold over saline ischemia. Note that FIRAZYR has NO contraindications — section 4 of the label reads 'None' — so this warning is carried entirely by a nonclinical section that a reader skimming for contraindications will never reach.
FIRAZYR (icatibant) Injection, for subcutaneous use — Full Prescribing Information — FDA, 19 January 2024“The B2 receptor has been implicated in the cardioprotective effects of bradykinin and antagonism of this receptor could potentially have negative cardiovascular effects during reperfusion after acute ischemia. … There is limited human experience in acute ischemia. FIRAZYR should be used during acute coronary ischemia, unstable angina pectoris, or in the weeks following a stroke only if the benefit exceeds the theoretical risk to the patient.”
Checked against the source on .In animals, daily subcutaneous administration of icatibant to rats and dogs caused ovarian, uterine, and testicular atrophy or degeneration and adverse effects on the mammary and prostate glands. The labeling records that these toxicities did NOT occur in dogs treated twice a week for 9 months.
The contrast in the label's own words is the finding, and it is the reason this is a signal rather than a scare. FDA's Summary Review states the reproductive toxicities 'would not preclude approval given the severity of HAE disease and the fact that animals were dosed daily, whereas humans will receive icatibant intermittently'. That reasoning is entirely contingent on intermittent use for acute attacks — which is what the approved indication describes and what any prophylactic or continuous off-label pattern would not. The specific exposure figures in the label are elided here under this site's no-dosing policy; no finding above depends on them. Separately, the label reports two-year carcinogenicity studies in mice and rats with no evidence of tumorigenicity, and negative genotoxicity across the Ames test, a chromosome aberration assay and the mouse micronucleus test.
FIRAZYR (icatibant) Injection, for subcutaneous use — Full Prescribing Information — FDA, 19 January 2024“Daily subcutaneous administration of icatibant to rats and dogs caused ovarian, uterine, and testicular atrophy/degeneration and adverse effects on the mammary and prostate glands. … In contrast to the effects of daily icatibant administration, toxicity to the ovary, uterus, testis, mammary gland, and prostate did not occur in dogs treated twice a week for 9 months.”
Checked against the source on .In animal reproduction studies, icatibant administered subcutaneously during the period of organogenesis did not cause structural abnormalities in rats or rabbits; however, premature birth and abortion were observed in rabbits, decreased embryofetal survival was observed in rabbits, and in a rat pre- and post-natal development study delayed parturition was observed which resulted in deaths of dams, with fetal death and early pup deaths also observed. Available human data from published literature and the pharmacovigilance database have not identified a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes.
Both halves belong on the page. The human signal is reassuring and the animal signal is not, and a record that reported either alone would be misleading. The exposure multiples the label attaches to each animal finding are elided under this site's no-dosing policy. The label does not state a conclusion about human pregnancy risk beyond the sentence quoted, and neither does this record.
FIRAZYR (icatibant) Injection, for subcutaneous use — Full Prescribing Information — FDA, 19 January 2024“Available data from published literature and the pharmacovigilance database with Firazyr (icatibant) use in pregnant women have not identified a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. In animal reproduction studies, icatibant, administered by the subcutaneous route during the period of organogenesis, did not cause structural abnormalities in rats or rabbits; however, premature birth and abortion were observed in rabbits …”
Checked against the source on .Across repeated treatment in the controlled trials, 4 patients tested positive for anti-icatibant antibodies, three of whom had subsequent negative tests, and no hypersensitivity or anaphylactic reactions were reported. Postmarketing experience with FIRAZYR has identified urticaria.
Included because immunogenicity is the open question for every injected peptide on this site, and icatibant is one of the few where it was actually measured in a controlled programme rather than left unstudied. The label's own caveat on the postmarketing entry applies: these events are reported voluntarily from a population of uncertain size, so frequency cannot be reliably estimated and causality cannot be established. FDA's Summary Review is blunter on the trial data — 'Immunogenicity was not an issue with icatibant' — but that assessment covers a safety database FDA itself described as small, 236 unique patients at the time of approval.
FIRAZYR (icatibant) Injection, for subcutaneous use — Full Prescribing Information — FDA, 19 January 2024“Across repeated treatment in the controlled trials, 4 patients tested positive for anti-icatibant antibodies. Three of these patients had subsequent tests which were negative. No hypersensitivity or anaphylactic reactions were reported with FIRAZYR. … The following adverse reactions have been identified during post approval use of FIRAZYR: urticaria.”
Checked against the source on .
Questions people actually ask
Every answer cites the document behind it. Where the honest answer is “nobody knows”, that is the answer you will get.
- Is icatibant FDA-approved in 2026?
Yes. FDA approved Firazyr (icatibant) injection under NDA 022150 on 25 August 2011, writing in the approval letter that the application 'provides for the use of Firazyr (icatibant) Injection for the treatment of acute attacks of hereditary angioedema in adults 18 years of age and older' and that 'It is approved, effective on the date of this letter'. The application is held today by Takeda Pharmaceuticals U.S.A. and carries prescription marketing status in FDA's product records; six generic icatibant acetate injection products are also approved. Read the indication rather than the approval: icatibant is approved for treating acute attacks of a specific inherited disorder in adults, not for angioedema generally, not for routine prevention of attacks, and not for anyone under 18.
NDA 022150 — NDA Approval Letter, Firazyr (icatibant acetate) Injection — FDA, 25 August 2011“This new drug application provides for the use of Firazyr (icatibant) Injection for the treatment of acute attacks of hereditary angioedema in adults 18 years of age and older. We have completed our review of this application, as amended. It is approved, effective on the date of this letter, for use as recommended in the enclosed agreed-upon labeling text.”
Checked against the source on .- Is Firazyr approved for children?
No. The FDA-approved labeling for FIRAZYR confines the indication to 'adults 18 years of age and older', and section 8.4 states that 'Safety and effectiveness in pediatric patients below the age of 18 years have not been established.' That gap is not merely an unstudied box: the same section reports that subcutaneous daily administration of icatibant to young rats during the juvenile period of development delayed the sexual maturation of male reproductive tissues, and that impaired fertility and reproductive performance were also observed in male rats at the end of the postnatal treatment period, effects the label attributes to antagonism of the bradykinin B2 receptor. Note also that the approval letter records the sponsor as EXEMPT from the pediatric assessment normally required under the Pediatric Research Equity Act, because the product carried orphan drug designation for this indication.
FIRAZYR (icatibant) Injection, for subcutaneous use — Full Prescribing Information — FDA, 19 January 2024“Safety and effectiveness in pediatric patients below the age of 18 years have not been established.”
Checked against the source on .- Is icatibant approved for angioedema caused by ACE inhibitors?
No. The FDA-approved indication for FIRAZYR is confined to acute attacks of HEREDITARY angioedema in adults, and angioedema induced by an ACE inhibitor is a different condition that is not named in it. The label goes further than silence on this point: section 7.1 states that FIRAZYR 'has the potential to have a pharmacodynamic interaction with ACE inhibitors where FIRAZYR may attenuate the antihypertensive effect of ACE inhibitors' and that 'Clinical trials to date have excluded subjects taking ACE inhibitors.' So the patients most often reached for with icatibant off-label are precisely the patients the approval's evidence base does not contain. The trial that was later run in them is a separate question, answered separately, and it did not go the way the mechanism predicted.
FIRAZYR (icatibant) Injection, for subcutaneous use — Full Prescribing Information — FDA, 19 January 2024“FIRAZYR is a bradykinin B2 receptor antagonist and thereby has the potential to have a pharmacodynamic interaction with ACE inhibitors where FIRAZYR may attenuate the antihypertensive effect of ACE inhibitors. Clinical trials to date have excluded subjects taking ACE inhibitors.”
Checked against the source on .- Did icatibant work for ACE inhibitor-induced angioedema in clinical trials?
No — the Phase 3 trial failed. In a randomised, placebo-controlled trial at 31 centers in 4 countries (the CAMEO study, registered as NCT01919801, sponsor Shire), 121 adults on ACE inhibitors presenting within 12 hours of at least moderately severe angioedema were randomised 1:1 to icatibant or placebo. The investigators reported: 'We observed no difference in time to meeting discharge criteria between groups (median, 4.0 hours in each group; P = .63). There also was no difference in time to onset of symptom relief … or any other secondary end point.' Their stated conclusion was that 'Icatibant was no more efficacious than placebo in at least moderately severe ACE-I-induced angioedema of the upper airway.' An earlier and much smaller phase 2 study published in the New England Journal of Medicine in 2015 (Baş et al., 27 patients in the per-protocol population, registered as NCT01154361) had reported a shorter time to complete resolution of edema with icatibant — but that study compared icatibant against a glucocorticoid-plus-antihistamine regimen rather than against placebo, and the larger placebo-controlled trial that followed did not reproduce the result. The authors of the Phase 3 trial noted that more than 90% of their subjects received corticosteroids, antihistamines, or epinephrine before the study drug.
Sinert R, et al. Randomized Trial of Icatibant for Angiotensin-Converting Enzyme Inhibitor-Induced Upper Airway Angioedema. J Allergy Clin Immunol Pract 2017;5(5):1402-1409 — PubMed, 25 May 2017“We observed no difference in time to meeting discharge criteria between groups (median, 4.0 hours in each group; P = .63). There also was no difference in time to onset of symptom relief … or any other secondary end point. … Icatibant was no more efficacious than placebo in at least moderately severe ACE-I-induced angioedema of the upper airway.”
Checked against the source on .- Why did FDA reject Firazyr in 2008 before approving it in 2011?
FDA's Division Director wrote that 'The original NDA was submitted in October 2007, and a Not Approval action was taken in April 2008, because substantial evidence of efficacy was not demonstrated in two pivotal studies. The original NDA included one placebo-controlled study that did not show efficacy, and another tranexamic acid (TA) active-controlled study that showed efficacy. Demonstration of efficacy in the TA active-controlled study was not considered adequate for approval because TA is not approved for the treatment of acute attacks of HAE.' The placebo-controlled study was FAST-1, which missed its prespecified primary endpoint (p = 0.142 against placebo for all attacks, per FDA's own table). The sponsor then ran a third trial, FAST-3, also placebo-controlled, which FDA reported was statistically superior to placebo on its prespecified endpoint — and approval followed in August 2011. The reason this is worth knowing is that it is invisible from the label: an approved drug reads as though its evidence arrived clean, and here FDA is on record that it did not.
Summary Review of Regulatory Action — NDA 22-150, Firazyr (icatibant) — FDA, 24 August 2011“The original NDA was submitted in October 2007, and a Not Approval action was taken in April 2008, because substantial evidence of efficacy was not demonstrated in two pivotal studies. The original NDA included one placebo-controlled study that did not show efficacy, and another tranexamic acid (TA) active-controlled study that showed efficacy. Demonstration of efficacy in the TA active-controlled study was not considered adequate for approval because TA is not approved for the treatment of acute attacks of HAE.”
Checked against the source on .- Is there a generic version of Firazyr?
Yes. FDA's Drugs@FDA records list six approved abbreviated new drug applications for icatibant acetate injection alongside the originator NDA 022150, all in prescription marketing status and all carrying therapeutic equivalence code AP: Teva (ANDA 210118, approved 2019-07-15), Jiangsu Hansoh (ANDA 211021, 2020-03-09), Fresenius Kabi (ANDA 208317, 2020-06-18), Cipla (ANDA 212446, 2020-07-13), Eugia (ANDA 213521, 2023-08-14) and Alembic (ANDA 213773, 2024-06-14). Two things follow. A generic is approved as therapeutically equivalent to the reference product for the REFERENCE PRODUCT'S indication, so the arrival of generics widened availability and did not widen the approved use — every one of these is approved for acute attacks of hereditary angioedema in adults. And an approved generic is an approved drug product: none of this says anything about compounded, imported or research-labelled material sold under the same name.
Drugs@FDA records for icatibant (openFDA drug/drugsfda API) — FDA, 31 July 2026Checked against the source on .