Treats confirmed Fabry disease. BLA 761161, held by Chiesi Farmaceutici Spa. Pegunigalsidase Alfa-Iwxj.
As of Nov 13, 2026, BLA 761161 (Elfabrio), held by Chiesi Farmaceutici Spa, was first approved by FDA on May 9, 2023, with 0 approved supplements and 1 published complete response letter.
ELFABRIO is indicated for the treatment of adults with confirmed Fabry disease.
| Date | Submission | Status | Documents |
|---|---|---|---|
| May 9, 2023 | Original applicationNew molecular entity · Priority review | Approved |
| Letter | Product | Now |
|---|---|---|
| Apr 27, 2021 | PRX-102Additional Information | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Elfabrio20MG/10ML · vial; single-use | Pegunigalsidase Alfa-Iwxj | Rx |
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
