The FDA is set to make four important decisions this week, including the approval of Argenx’s subcutaneous efgartigimod for adults with generalized myasthenia gravis, Aldeyra’s investigational intravitreal injection ADX-2191 for primary vitreoretinal lymphoma, Intercept Pharmaceuticals’ obeticholic acid for pre-cirrhotic liver fibrosis due to non-alcoholic steatohepatitis, and Sarepta’s gene therapy candidate SRP-9001 for Duchenne muscular dystrophy. These decisions are highly anticipated by patients and industry alike.
This week, the FDA will make four crucial decisions that include approving a subcutaneous version of Argenx's efgartigimod for adults with generalized myasthenia gravis (gMG), an intravitreal injection called ADX-2191 for primary vitreoretinal lymphoma developed by Aldeyra, obeticholic acid from Intercept Pharmaceuticals as treatment for pre-cirrhotic liver fibrosis caused by non-alcoholic steatohepatitis, and Sarepta's gene therapy candidate SRP-9001 which could be the first gene therapy