1. Scrip
  2. >>Therapy Areas
  3. >>Blood and Clotting

New Data Reinforces Potential Of Sanofi's Sutimlimab After Shock FDA Snub

Second Positive Phase III Trial In Cold Agglutinin Disease

 
• By Kevin Grogan

Having suffered a setback last year when deficiencies at a third-party manufacturer scuppered hopes of a quick US approval of sutimlimab for cold agglutinin disease, Sanofi has released more promising data on its C1s inhibitor at the European Hematology Association meeting.

Lyon France, 3 October 2017: White logo of the french multinational pharmaceutical company Sanofi on their glass office building in Lyon France

Seven months after a surprise rejection from regulators in the US, Sanofi has presented new late-stage data on its rare blood disorder drug sutimlimab which will provide the basis for a submission in Europe and a resubmission Stateside in the coming months.

The French giant has presented data at the European Hematology Association meeting on sutimlimab from a second Phase III study called CADENZA which could see the first-in-class C1s inhibitor become the first approved treatment for hemolysis in people with cold agglutinin disease (CAD), a chronic

More from Blood and Clotting

More from Therapy Areas

In Brief: Positive New Data For Aptose’s Triplet Therapy In 1L AML

 
• By Sushmita Panda

Aptose’s tuspetinib triplet shows early mutation-agnostic promise in new data from Phase I/II program for frontline acute myeloid leukemia.

Chinese Firms Build Obesity Clinical Pipeline But Face Wider Hurdles

 
• By Xu Hu

Despite the ability to initiate clinical trials quickly and having strong manufacturing capacity, Chinese companies are facing multiple challenges in the obesity space.

Aldeyra Plans To File Reproxalap Again With New Dry Eye Symptom Data

 
• By Joseph Haas

The biotech hopes a third time will be the charm after two FDA complete responses, with plans to position its eye drop as offering quicker onset of action.