European Fee Declines To Renew Advertising and marketing Authorization Of Translarna Duchenne Muscular Dysfunction – PTC Therapeutics (NASDAQ:PTCT)

The European Fee (EC) adopted the opinion of the Committee for Medicinal Merchandise for Human Use (CHMP) of the European Medicines Company (EMA) to not renew the authorization of PTC Therapeutics, Inc.’s PTCT Translarna (ataluren) for nonsense mutation Duchenne muscular dystrophy (nmDMD).

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Whereas this motion successfully removes the drug’s conditional advertising and marketing authorization within the European Financial Space, the EC indicated that particular person international locations inside the European Union might leverage Articles 117(3) and 5(1) of the EU Directive 2001/83 to permit continued use of Translarna.

“We’re in fact disillusioned that after this extended interval of assessment the European Fee has determined to undertake the CHMP destructive opinion on Translarna,” mentioned Matthew B. Klein, PTC Therapeutics CEO in a press release on Friday.

“We stay up for engaged on a country-by-country foundation to offer business drug the place potential.”

In Could 2024, PTC Therapeutics introduced that the European Fee (EC) has determined to not undertake the CHMP’s destructive opinion on the annual renewal of Translarna’s conditional advertising and marketing authorization (ataluren) and has returned the opinion to the CHMP for re-evaluation. 

Translarna’s web product revenues have been $339.9 million for the total yr 2024, in comparison with $355.8 million for the total yr 2023.

In 2024, PTC submitted 4 regulatory approval functions to the FDA, all of which have been accepted for assessment, together with Translarna for nmDMD.

Value Motion: PTCT inventory is down 1.76% at $54.02 on the final verify Friday.

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