Treats paroxysmal nocturnal hemoglobinuria (PNH). NDA 215014, held by Apellis Pharms. Pegcetacoplan.
As of Nov 13, 2026, NDA 215014 (Empaveli), held by Apellis Pharms, was first approved by FDA on May 14, 2021, with 7 approved supplements and 0 published complete response letters.
EMPAVELI is a complement inhibitor indicated: for the treatment of adult patients with paroxysmal nocturnal hemoglobinuria (PNH). for the treatment of adult and pediatric patients aged 12 years and older with C3 glomerulopathy (C3G) or primary immune-complex membranoproliferative glomerulonephritis (IC-MPGN), to reduce proteinuria and the loss of kidney function. 1.1 Paroxysmal Nocturnal Hemoglobinuria EMPAVELI is indicated for the treatment of adult patients with paroxysmal nocturnal hemoglobinuria (PNH). 1.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Aug 20, 2026 | Supplement 12Efficacy (new indication or use) · Standard review | Approved | |
| Jul 28, 2025 | Supplement 11Efficacy (new indication or use) · Priority review | Approved | |
| Feb 8, 2023 | Supplement 2Efficacy (new indication or use) · Standard review | Approved | |
| May 14, 2021 | Original applicationNew molecular entity · Priority review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Empaveli1080MG/20ML (54MG/ML) · solution;subcutaneous | Pegcetacoplan | RxReference drug |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Aug 20, 2026 | Supplement 12Efficacy (new indication or use) · Standard review | Approved | |
| Jul 28, 2025 | Supplement 11Efficacy (new indication or use) · Priority review | Approved | |
| Jun 10, 2025 | Supplement 10Labeling · Standard review | Approved | |
| Oct 7, 2024 | Supplement 8REMS | Approved | |
| Feb 8, 2024 | Supplement 6Labeling · Standard review | Approved | |
| Sep 28, 2023 | Supplement 3Labeling · Standard review | Approved | |
| Feb 8, 2023 | Supplement 2Efficacy (new indication or use) · Standard review | Approved | |
| May 14, 2021 | 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
