Logo

Sanofi’s Enjaymo (sutimlimab) Receives EC’s Approval for Hemolytic Anemia in Adult Patients with Cold Agglutinin Disease

Share this

Sanofi’s Enjaymo (sutimlimab) Receives EC’s Approval for Hemolytic Anemia in Adult Patients with Cold Agglutinin Disease

Shots:

• The approval was based on the part A P-III trials (CADENZA) & (CARDINAL) evaluating Enjaymo (6.5/7.5g, IV on    Day 0, Day 7, and then EOW for ~26wk.) vs PBO in 42 & 24 patients with CAD. The product will be available as a    50mg/mL solution for infusion

• Both the trial met its 1EPs & 2EPs i.e., In the (CADENZA) study, the therapy showed inhibition of hemolysis, an      increase in Hb levels & improvement in FACIT-Fatigue scores along with an acceptable safety profile & well-            tolerated, patients experienced 1 TEAE (96% vs 100%) without a recent history of blood transfusion

• In the (CARDINAL) study, the efficacy was evaluated based on the 1EPs & different 2EPs incl. improvements in      Hb, normalization of bilirubin & FACIT-fatigue score who have had a recent blood transfusion

Ref: Globenewswire | Image: Sanofi

Click here to­ read the full press release 

Senior Editor

Neha is a Senior Editor at PharmaShots. She is passionate and very enthusiastic about recent updates and developments in the life sciences and pharma industry. She covers Biopharma, MedTech, and Digital health segments along with different reports at PharmaShots. She can be contacted at connect@pharmashots.com.

Share this article on WhatsApp, LinkedIn and Twitter

Join the PharmaShots family of 12000+ subscribers

I accept the Terms and Conditions