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European Medicines Agency Renews Conditional Marketing Authorisation of Translarna

Posted

12 November 2016

CHMP Recommends Renewal of Translarna's™ Marketing Authorization for Nonsense Mutation Duchenne Muscular Dystrophy Based on Continued Positive Benefit-Risk Assessment

--PTC to conduct a post-authorization clinical trial --

SOUTH PLAINFIELD, N.J., Nov. 11, 2016 /PRNewswire/ -- PTC Therapeutics, Inc. (NASDAQ: PTCT) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended the renewal of the conditional marketing authorization of Translarna™ (ataluren) for the treatment of nonsense mutation Duchenne muscular dystrophy (nmDMD) in ambulatory patients five years and older. In connection with the renewal, the marketing authorization will include a specific obligation to conduct an additional long-term post-authorization trial.

Read more: http://ir.ptcbio.com/releaseDetail.cfm?ReleaseID=9...