For multiple myeloma. NDA 217159, held by Ayrmid Pharma. Motixafortide Acetate.
As of Nov 13, 2026, NDA 217159 (Aphexda), held by Ayrmid Pharma, was first approved by FDA on Sep 8, 2023, with 1 approved supplement and 0 published complete response letters.
APHEXDA is indicated in combination with filgrastim (G-CSF) to mobilize hematopoietic stem cells to the peripheral blood for collection and subsequent autologous transplantation in patients with multiple myeloma.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Sep 8, 2023 | Original applicationNew molecular entity · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| AphexdaEQ 62MG BASE/VIAL · powder;subcutaneous | Motixafortide Acetate | RxReference drug |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Mar 11, 2026 | Supplement 9Labeling · Standard review | Approved | |
| Sep 8, 2023 | Original applicationNew molecular entity · Standard 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
