EMA/CHMP backing for several new medicines

28 July 2018

In what was clearly a bumper session for the regulator, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommended 16 medicines for approval at its July 2018 meeting.

Two of these were for pediatric diseases and one a hereditary condition and are covered in a separate story.

Symkevi (tezacaftor/ivacaftor), from Vertex Pharmaceuticals (Nasdaq: VRTX), received a positive opinion for the treatment of cystic fibrosis in patients aged 12 and older. Symkevi was designated as an orphan medicine during its development.

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