(CercleFinance.com) – The Scientific Committee of the European Medicines Agency (EMA) yesterday issued a favorable opinion concerning the granting of a marketing authorization for Enjaymo, Sanofi’s treatment for patients with the disease of cold agglutinins, can we read today on the site of the agency.
Enjaymo, a treatment that reduces the need for blood transfusions to treat hemolysis (destruction of red blood cells) in people with cold agglutinin disease, had been approved by the US Food and Drug Administration (FDA) United last February.
After the favorable opinion of the Committee for Medicinal Products for Human Use (CHMP) of the EMA, the file must now be examined by the European Commission (EC).