Santhera appeals idebenone delay

Swiss drugmaker Santhera Pharmaceuticals has requested re-examination of the negative opinion by the European Medicines Agency (EMEA) Committee for Medicinal Products for Human Health (CHMP) regarding its Friedreich's Ataxia drug Sovrima (idebenone), which was rejected despite the progress of ongoing Phase III trials.

Last month (Marketletter July 28), the CHMP informally advised that it would not support a positive opinion for the Marketing Authorization Application for SNT-MC17/idebenone for FA, as Santhera's ongoing late-stage studies prevented the committee from reviewing the application under the EMEA Guideline on Clinical Trials in Small Populations, which was requested by Santhera in its MAA filing. The Committee believes it cannot approve the drug before data from at least one of the advanced Phase III programs in Europe and the USA are submitted for review.

Company chief executive Klaus Schollmeier, said: "we are aware of the challenges of such re-examination processes, but we believe that the clinical benefit afforded to Friedreich's Ataxia patients was underestimated in the initial assessment." The drug was recently approved in Canada (Marketletter July 28), where it shall be sold as Catena. In Europe, the drug is partnered with Japan's Takeda.