Enjaymo (sutimlimab)
OrphanAdditional monitoring
- Region
- 🇪🇺 EU
- Active substance
- sutimlimab
- Company
- Recordati Rare Diseases
- Status
- Authorised
- Therapeutic area
- Hemolysis; Anemia, Hemolytic, Autoimmune
- CHMP opinion
- Thu 15 Sep 2022
- EU approval
- Tue 15 Nov 2022
- Designations
- Orphan, Additional monitoring
- Application
- EMEA/H/C/005776
- ATC
- L04AJ04
- Official record
- www.ema.europa.eu
Indication
Enjaymo is indicated for the treatment of haemolytic anaemia in adult patients with cold agglutinin disease (CAD).
Regulatory milestones
No milestones recorded in the last year.
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Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.