The European Medicines Agency (EMA) has upheld a decision to deny marketing authorization for Masitinib, an oral treatment for ALS, due to concerns about the reliability of the data supporting the drug. Masitinib is intended to reduce inflammation and protect nerve cells from damage in ALS patients. The EMA also confirmed the decision to not renew the conditional marketing authorization for Translarna, a treatment for Duchenne muscular dystrophy, as its efficacy could not be confirmed. Both decisions were made by the Committee for Medicinal Products for Human Use (CHMP) and are subject to ratification by the European Commission.
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EMA Confirms Rejection of Neurodegenerative Disease Drugs
