FDA nod for Enjaymo, first treatment for a rare form of hemolytic anemia

The US Food and Drug Administration has approved Enjaymo (sutimlimab-jome) to decrease the need for red blood cell transfusion due to hemolysis in adults with cold agglutinin disease (CAD).

Developed by French pharma major Sanofi (Euronext: SAN), Enjaymo is the first and only approved treatment for people with CAD and works by inhibiting the destruction of red blood cells (hemolysis).

Sanofi gained rights to the drug along with its  $11.6 billion acquisition of Bioverativ in 2018, but it has faced regulatory setbacks; the FDA hit Sanofi with a complete response letter in November 2020, citing deficiencies in a pre-inspection of a contract manufacturer's plant.