European Commission refuses renewal of Translarna (ataluren) marketing authorization in EU

PTC THERAPEUTICS, INC.

EC adopted CHMP negative opinion; renewal of conditional MA for nonsense mutation DMD denied.
Drug effectively removed from European Economic Area; authorization ends.
EC indicated EU member states may allow continued use under Articles 117(3) and 5(1) of Directive 2001/83.
PTC CEO expresses disappointment; plans to work country-by-country to maintain commercial access.
Decision based on CHMP conclusion that efficacy was not established and benefit-risk not confirmed.

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