EMA Appeal Pursues Release of PTC Therapeutics’ Clinical Report on Translarna

The EMA is appealing a temporary injunction from the General Court of the European Union that prevents the agency from releasing a clinical study report on PTC Therapeutics’ Duchenne muscular dystrophy drug Translarna.

The temporarily injunction is part of an ongoing suit filed by PTC Therapeutics to keep the agency from releasing the documents to a third party, the EMA said.

The EMA had intended to release the documents with the appropriate redactions under the provisions of the European Commission’s regulation on public access to agency documents — which is often referred to as a “transparency regulation” — but the company argued that the disclosure would violate its right to protect commercially confidential information.