Prevents Respiratory Syncytial Virus (RSV) lower respiratory tract disease. BLA 761328, held by Astrazeneca AB. Nirsevimab-Alip.
As of Nov 13, 2026, BLA 761328 (Beyfortus), held by Astrazeneca AB, was first approved by FDA on Jul 17, 2023, with 4 approved supplements and 0 published complete response letters.
BEYFORTUS is indicated for the prevention of Respiratory Syncytial Virus (RSV) lower respiratory tract disease in: Neonates and infants born during or entering their first RSV season. Children up to 24 months of age who remain vulnerable to severe RSV disease through their second RSV season. BEYFORTUS is a respiratory syncytial virus (RSV) F protein-directed fusion inhibitor indicated for the prevention of RSV lower respiratory tract disease in: Neonates and infants born during or entering their first RSV season. Children up to 24 months of age who remain vulnerable to severe RSV disease through their second RSV season.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Oct 20, 2025 | Supplement 12Efficacy (new indication or use) · Standard review | Approved | |
| Aug 22, 2024 | Supplement 5Efficacy (new indication or use) · Standard review | Approved | |
| Jul 17, 2023 | Original applicationNew molecular entity · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Beyfortus50MG · injectable;injection | Nirsevimab-Alip | Rx |
| Beyfortus100MG · injectable;injection | Nirsevimab-Alip | Rx |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Apr 7, 2026 | Supplement 19Labeling · Standard review | Approved | |
| Oct 20, 2025 | Supplement 12Efficacy (new indication or use) · Standard review | Approved | |
| Aug 22, 2024 | Supplement 5Efficacy (new indication or use) · Standard review | Approved | |
| Feb 23, 2024 | Supplement 7Labeling | Approved | |
| Jul 17, 2023 | Original applicationNew molecular entity · Standard review | Approved |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed weekly; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
