PTCT - PTC Therapeutics To Withdraw Its Conditionally Approved Rare Muscle Disorder Disorder Drug In Europe | Benzinga
Thursday, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) issued a negative opinion following the re-examination procedure for the conditional marketing authorization of PTC Therapeutics Inc’s (NASDAQ:PTCT) Translarna (ataluren).
“We are disappointed that the CHMP has maintained its negative opinion on the Translarna authorization, which will result in the withdrawal of a therapy for patients in Europe with nonsense mutation Duchenne Muscular Dystrophy that the data support is safe and effective,” said Matthew Klein, Chief Executive Officer of PTC Therapeutics.
In September 2023, the CHMP gave a negative opinion on converting the conditional marketing authorization to ...