FDA Approves Treatment for Rare Autoimmune Disorder

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FDA has approved sutimlimab-jome as a treatment for hemolysis in individuals with CAD.

Sanofi announced on Feb. 4, 2022, that FDA approved Enjaymo (sutimlimab-jome) for adults with cold agglutinin disease (CAD). According to a company press release, the approval makes sutimlimab-jome the first and only drug designed to treat the destruction of red blood cells (hemolysis) in individuals with CAD.

CAD is a rare autoimmune hemolytic anemia caused by cold agglutinins binding to the surface of red blood cells. This causes the body to mistakenly attack otherwise healthy red blood cells, which can result in hemolysis. This can result in fatigue, weakness, shortness of breath, light-headedness, chest pain, irregular heartbeat, and various other potential complications. According to the press release, the disorder affects an estimated 5000 people in the United States.

Sutimlimab-jome is a humanized monoclonal antibody designed to selectively target and inhibit the complement 1 (C1) protein in the classical complement pathway. Through this, it inhibits the activation of the complaint cascade in the immune system, consequently inhibiting C1-activated hemolysis.


“Until now, people living with cold agglutinin disease haven’t had an approved treatment option to manage the constant destruction of red blood cells. Without healthy, viable red blood cells, a chain reaction of debilitating signs and symptoms can be triggered, starting with severe anemia,” said Bill Sibold, executive vice-president, head of Specialty Care, Sanofi, in the press release. “Enjaymo is the only approved treatment to inhibit red blood cell destruction in CAD and help stop the chain reaction from the start.”

Source: Sanofi