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EMA’s CHMP green-lights Casgevy, Skyclarys and Velsipity
December highlights also include confirmation of non-renewal for Blenrep, plus recommendations for two therapies for neglected tropical diseases
December 16, 2023 12:06 AM UTC
At its December meeting, EMA’s CHMP recommended approval of three new medicines, Casgevy, Skyclarys and Velsipity, and label extensions for four. The agency also confirmed its non-renewal of Blenrep.
Just weeks after Casgevy exagamglogene autotemcel became the world’s first gene editing therapy via approval in the U.K., CHMP has recommended conditional approval of Casgevy for transfusion-dependent β-thalassemia and sickle cell disease. ...