Treats erythrocytosis. NDA 220605, held by Takeda Pharms Am. Rusfertide Acetate.
As of Nov 14, 2026, NDA 220605 (Mimrylo), held by Takeda Pharms Am, was first approved by FDA on Aug 28, 2026, with 0 approved supplements and 0 published complete response letters.
MIMRYLO is indicated for the treatment of erythrocytosis in adults with polycythemia vera (PV).
| Date | Submission | Status | Documents |
|---|---|---|---|
| Aug 28, 2026 | Original applicationNew molecular entity · Priority review | Approved |
| MimryloEQ 9.5MG BASE/VIAL · powder;subcutaneous | Rusfertide Acetate | RxReference drug |
| MimryloEQ 19MG BASE/VIAL · powder;subcutaneous | Rusfertide Acetate | RxReference drug |
| MimryloEQ 28MG BASE/VIAL · powder;subcutaneous | Rusfertide Acetate | RxReference drug |
| MimryloEQ 41MG BASE/VIAL · powder;subcutaneous | Rusfertide Acetate | RxReference drug |
| MimryloEQ 54MG BASE/VIAL · powder;subcutaneous | Rusfertide Acetate | RxReference drug |
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
