Sanofi (SNY - Free Report) announced that the FDA has granted priority review to its biologics license application (BLA) seeking approval of its investigational monoclonal antibody sutimlimab for the treatment of hemolysis in adult patients with cold agglutinin disease (CAD).
Patients with CAD, a serious, chronic, rare blood disorder, experience complications like chronic anemia and extreme fatigue as the disease causes the body’s immune system to mistakenly attack healthy red blood cells and cause their rupture (hemolysis). Sutimlimab works by targeting C1-activated hemolysis in patients with CAD. With the FDA granting priority review to the BLA, a decision is expected on Nov 13. If approved by the FDA, sutimlimab would become the first and only approved treatment for CAD patients.
So far this year, Sanofi’s shares have declined 3.8% compared with the industry’s 1.7% decline.
The BLA filing was based on positive data from a pivotal phase III study, CARDINAL. Data from the study showed that sutimlimab had a clinically meaningful effect on complement-mediated hemolysis, which is the cause of anemia and fatigue
Meanwhile, sutimlimab is also being evaluated in a phase III CADENZA study for CAD patients who have not recently had a blood transfusion. The candidate is also being studied for immune thrombocytopenic purpura.
Sutimlimab was added to Sanofi’s pipeline with the 2018 acquisition of Bioverativ, which was focused on developing therapies for hemophilia and other rare blood disorders. Bioverativ was spun-off by Biogen (BIIB - Free Report) in February 2017 and traded with the ticker symbol “BIVV” on the NASDAQ stock market until it was bought by Sanofi.
Sanofi’s rare blood disorders franchise recorded sales of €294 million in the first quarter of 2020, representing an increase of 3.6% year over year.
Key players in the rare blood disorder market are Alexion Pharmaceuticals (ALXN - Free Report) , Global Blood Therapeutics (GBT - Free Report) and Regeneron Pharmaceuticals among others.
Sanofi currently has a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
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