The judgement relates to the commission’s decision not to approve D&A Pharma’s application for a CMA for its alcohol dependence drug Hopveus (sodium oxybate). This came after a second negative opinion from the CHMP and after an ad-hoc expert group convened to re-examine the opinion at the request of the company.

One member of the ad-hoc group had provided consultancy services for several companies while another had been an investigator for a competing product. The General Court of the EU dismissed the case, but the firm appealed in the Court of Justice, which overturned the initial decision and stated that CHMP impartiality requirements also applied to expert groups consulted by the committee.

The court also noted that the CHMP should have consulted the scientific advisory group in the re-examination process, rather than the ad hoc group.

European Commission Dangles Conditional Approval Reprieve For PTC Therapeutics’ Translarna

More from Europe

More from Geography