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PTC Therapies Announces a Positive Label Update for its Translarna

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 by a majority of votes to remove the statement

Benzinga · -

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 by a majority of votes to remove the statement "efficacy has not been demonstrated in non-ambulatory patients" from the SmPC for Translarna™ (ataluren). This label change enables healthcare professionals to use their clinical judgement to make treatment decisions for their patients on Translarna who have lost ambulation.1 The change also should support reimbursement agencies granting continued access to Translarna for patients who become non-ambulatory during the course of their treatment. The CHMP's positive opinion is subject to final approval by the European Commission, which is normally granted in a two-month time frame.