BLA 761195, held by Argenx BV. Efgartigimod Alfa.
As of Nov 13, 2026, BLA 761195 (Vyvgart), held by Argenx BV, was first approved by FDA on Dec 17, 2021, with 5 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| May 8, 2026 | Supplement 16Efficacy (new indication or use) · Priority review | Approved | |
| Oct 17, 2025 | Supplement 12Efficacy (new indication or use) · Standard review | Approved | |
| Aug 8, 2024 | Supplement 4Efficacy (new indication or use) · Standard review | Approved | |
| Dec 17, 2021 | Original applicationNew molecular entity · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Vyvgart400MG · injectable;injection | Efgartigimod Alfa | Rx |
| Date | Submission | Status | Documents |
|---|---|---|---|
| May 8, 2026 | Supplement 16Efficacy (new indication or use) · Priority review | Approved | |
| Oct 17, 2025 | Supplement 12Efficacy (new indication or use) · Standard review | Approved | |
| Aug 8, 2024 | Supplement 4Efficacy (new indication or use) · Standard review | Approved | |
| Jul 24, 2024 | Supplement 6Labeling · Standard review | Approved | |
| Dec 12, 2023 | Supplement 3Labeling · Standard review | Approved | |
| Dec 17, 2021 | 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
