Treats adenosine deaminase severe combined immune deficiency (ADA-SCID). BLA 761092, held by Chiesi USA Inc. Elapegademase-Lvlr.
As of Nov 13, 2026, BLA 761092 (Revcovi), held by Chiesi USA Inc, was first approved by FDA on Oct 5, 2018, with 1 approved supplement and 0 published complete response letters.
REVCOVI is indicated for the treatment of adenosine deaminase severe combined immune deficiency (ADA-SCID) in pediatric and adult patients.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Oct 5, 2018 | Original applicationNew molecular entity · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Revcovi1.6MG/ML · injectable;injection | Elapegademase-Lvlr | Rx |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Dec 5, 2020 | Supplement 5Labeling · Standard review | Approved | |
| Oct 5, 2018 | Original applicationNew molecular entity · Standard 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
