PTC: CHMP Adopts Positive Opinion For Extension Of Evrysdi Authorization To Include Infants

(RTTNews) - PTC Therapeutics, Inc. (PTCT) announced that the Committee for Medicinal Products for Human Use has adopted a positive opinion for the extension of the Evrysdi marketing authorization to include infants under two months of age in the European Union. The final decision from the European Commission is expected later in the current year.

Evrysdi was based on PTC's splicing platform. Evrysdi is marketed by Roche and in the United States by Genentech, a member of the Roche Group. Roche leads the clinical development of Evrysdi as part of a collaboration with the SMA Foundation and PTC.

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