BLA 761304, held by Argenx BV. Efgartigimod Alfa And Hyaluronidase-Qvfc.
As of Nov 13, 2026, BLA 761304 (Vyvgart Hytrulo), held by Argenx BV, was first approved by FDA on Jun 20, 2023, with 8 approved supplements and 0 published complete response letters.
VYVGART HYTRULO is indicated for the treatment of adult patients with: generalized myasthenia gravis (gMG) chronic inflammatory demyelinating polyneuropathy (CIDP)
| Date | Submission | Status | Documents |
|---|---|---|---|
| May 8, 2026 | Supplement 18Efficacy (new indication or use) · Priority review | Approved | |
| Oct 17, 2025 | Supplement 10Efficacy (new indication or use) · Standard review | Approved | |
| Apr 10, 2025 | Supplement 8Efficacy (new indication or use) · Standard review | Approved | |
| Aug 8, 2024 | Supplement 3Efficacy (new indication or use) · Standard review | Approved | |
| Jun 21, 2024 | Supplement 5Efficacy (new indication or use) · Priority review | Approved | |
| Jun 20, 2023 | Original application | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Vyvgart Hytrulo1008MG;11200UNITS PER 5.6ML · injectable;injection | Efgartigimod Alfa And Hyaluronidase-Qvfc | Rx |
| Date | Submission | Status | Documents |
|---|---|---|---|
| May 8, 2026 | Supplement 18Efficacy (new indication or use) · Priority review | Approved | |
| Feb 26, 2026 | Supplement 19Labeling · Standard review | Approved | |
| Oct 17, 2025 | Supplement 10Efficacy (new indication or use) · Standard review | Approved | |
| Apr 10, 2025 | Supplement 8Efficacy (new indication or use) · Standard review | Approved | |
| Aug 8, 2024 | Supplement 3Efficacy (new indication or use) · Standard review | Approved | |
| Jun 21, 2024 | Supplement 5Efficacy (new indication or use) · Priority review | Approved | |
| Jun 21, 2024 | Supplement 6Labeling · Standard review | Approved | |
| Dec 12, 2023 | Supplement 2Labeling · Standard review | Approved | |
| Jun 20, 2023 | Original application | 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
