Treats hemolysis. BLA 761164, held by Recordati Rare Diseases, Inc.. Sutimlimab-Jome.
As of Nov 13, 2026, BLA 761164 (Enjaymo), held by Recordati Rare Diseases, Inc., was first approved by FDA on Feb 4, 2022, with 3 approved supplements and 1 published complete response letter.
ENJAYMO is a classical complement inhibitor indicated for the treatment of hemolysis in adults with cold agglutinin disease (CAD). Cold Agglutinin Disease
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jan 25, 2023 | Supplement 3Efficacy (new indication or use) · Priority review | Approved | |
| Feb 4, 2022 | Original applicationNew molecular entity · Priority review | Approved |
| Letter | Product | Now |
|---|---|---|
| Nov 13, 2020 | SutimlimabFacility Inspections | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Enjaymo1,100MG/22ML(50MG/ML) · injectable;injection | Sutimlimab-Jome | Rx |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Feb 8, 2024 | Supplement 4Labeling · Standard review | Approved | |
| Jan 25, 2023 | Supplement 3Efficacy (new indication or use) · Priority review | Approved | |
| Sep 23, 2022 | Supplement 1Manufacturing | Approved | |
| Feb 4, 2022 | Original applicationNew molecular entity · Priority 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
