Treats anemia. NDA 216196, held by Agios Pharms Inc. Mitapivat Sulfate.
As of Nov 13, 2026, NDA 216196 (Pyrukynd, Aqvesme), held by Agios Pharms Inc, was first approved by FDA on Feb 17, 2022, with 4 approved supplements and 0 published complete response letters.
AQVESME is indicated for the treatment of anemia in adults with alpha- or beta-thalassemia.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Dec 23, 2025 | Supplement 3Efficacy (new indication or use) · Standard review | Approved | |
| Feb 17, 2022 | Original applicationNew molecular entity · Priority review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| PyrukyndEQ 5MG BASE · tablet;oral | Mitapivat Sulfate | RxReference drug |
| PyrukyndEQ 20MG BASE · tablet;oral | Mitapivat Sulfate | RxReference drug |
| PyrukyndEQ 50MG BASE · tablet;oral | Mitapivat Sulfate | RxReference drug |
| AqvesmeEQ 100MG BASE · tablet;oral | Mitapivat Sulfate | RxReference drug |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Sep 28, 2026 | Supplement 7Manufacturing | Approved | |
| Apr 8, 2026 | Supplement 6Manufacturing | Approved | |
| Dec 23, 2025 | Supplement 3Efficacy (new indication or use) · Standard review | Approved | |
| Jan 3, 2025 | Supplement 4Labeling · Standard review | Approved | |
| Feb 17, 2022 | 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
