FDA expands label for Sanofi's Enjaymo

The US Food and Drug Administration (FDA) has approved the expanded indication for Enjaymo (sutimlimab-jome), the first and only treatment of hemolysis in adults with cold agglutinin disease (CAD), to include patients with or without a history of transfusions.

Developed by French pharma major Sanofi (Euronext: SAN), Enjaymo was first approved by the FDA in February 2022, to decrease the need for red blood cell transfusion due to hemolysis in adults with CAD. Sanofi gained rights to the drug along with its $11.6 billion acquisition of Bioverativ in 2018. The drug received European marketing authorization in November last year.

The efficacy supplemental Biologics License Application was evaluated under priority review and included long-term data from the pivotal CADENZA and CARDINAL studies.