BLA 761090, held by Dyax Corp.. Lanadelumab-Flyo.
As of Nov 14, 2026, BLA 761090 (Takhzyro), held by Dyax Corp., was first approved by FDA on Aug 23, 2018, with 4 approved supplements and 0 published complete response letters.
TAKHZYRO is indicated for prophylaxis to prevent attacks of hereditary angioedema (HAE) in adult and pediatric patients aged 2 years and older.
| Feb 3, 2023 | Supplement 10Efficacy (new indication or use) · Priority review | Approved | |
| Aug 23, 2018 | Original applicationNew molecular entity · Priority review | Approved |
| Takhzyro300MG/2ML (150MG/ML) · solution;subcutaneous | Lanadelumab-Flyo | Rx |
| Takhzyro300MG/2ML (150MG/ML) · solution;subcutaneous | Lanadelumab-Flyo | Rx |
| Aug 20, 2026 | Supplement 20Labeling · Standard review | Approved | |
| Feb 3, 2023 | Supplement 10Efficacy (new indication or use) · Priority review | Approved | |
| Feb 8, 2022 | Supplement 3Manufacturing | Approved | |
| Nov 16, 2018 | Supplement 1Labeling · Standard review | Approved | |
| Aug 23, 2018 | Original applicationNew molecular entity · Priority review | Approved |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
