Treats non–central nervous system manifestations of acid sphingomyelinase deficiency…. BLA 761261, held by Genzyme Corp. Olipudase Alfa-Rpcp.
As of Nov 13, 2026, BLA 761261 (Xenpozyme), held by Genzyme Corp, was first approved by FDA on Aug 31, 2022, with 2 approved supplements and 0 published complete response letters.
XENPOZYME is indicated for treatment of non–central nervous system manifestations of acid sphingomyelinase deficiency (ASMD) in adult and pediatric patients.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Aug 31, 2022 | Original applicationNew molecular entity · Priority review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Xenpozyme20MG · injectable;injection | Olipudase Alfa-Rpcp | Rx |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Dec 20, 2024 | Supplement 4Labeling · Standard review | Approved | |
| Dec 5, 2023 | Supplement 2Labeling · Standard review | Approved | |
| Aug 31, 2022 | Original applicationNew molecular entity · Priority review | 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
