Sanofi’s Enjaymo Approved for Cold Agglutinin Disease

The FDA has approved Sanofi’s Enjaymo (sutimlimab-jome) for treating adults with cold agglutinin disease, a rare autoimmune disease marked by the destruction of healthy red blood cells.

The approval was based on the results of a 24-patient phase 3 study, which demonstrated that the Enjaymo treatment achieved normal levels of hemoglobin without transfusion after the first five weeks in 54 percent of patients.

In late 2020, the FDA declined to approve Sanofi’s Biologics License Application for Enjaymo, citing problems at a third-party manufacturer that had to be resolved before the French drugmaker could be granted approval.

Sanofi plans to launch Enjaymo within weeks at a U.S. list price of $1,800 per vial.