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Sanofi (SNY) Blood Disorder Candidate Gets FDA's Rejection

Sanofi SNY announced that the FDA has issued a complete response letter (CRL) to its biologics license application (BLA) for its investigational drug, sutimlimab for the treatment of hemolysis in adult patients with cold agglutinin disease (CAD). The reason for the CRL is the identification of certain deficiencies by the FDA during a pre-license inspection of a third-party manufacturing facility. The CRL does not mention any clinical or safety deficiencies in the BLA.  Sanofi is working with the FDA and the third-party manufacturer to resolve the matter.

So far this year, Sanofi’s shares have risen 1.6% compared with the industry’s 1.0% increase.



Patients with CAD, a serious, chronic, rare blood disorder, experience complications like chronic anemia and extreme fatigue. This is due to the fact that 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.

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 in February 2017 and traded with the ticker symbol “BIVV” on Nasdaq until it was acquired by Sanofi.

Sanofi’s rare blood disorders franchise recorded sales of €900 million in the first half of 2020, representing an increase of 5.8% year over year.

Key players in the rare blood disorder market are Alexion Pharmaceuticals ALXN, Global Blood Therapeutics GBT and Regeneron Pharmaceuticals among others.

Sanofi currently has a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

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