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FDAnews Drug Daily Bulletin

CHMP Recommends 11 Medicines for Approval, Including Four Biosimilars

May 30, 2017

The European Medicines Agency’s Committee for Medicinal Products for Human Use recommended 11 medicines for approval, including one new cell therapy, four new drugs and four biosimilars.

The committee recommended approvals for: Gedeon Richter’s Reagila (cariprazine), for schizophrenia; LEO Pharma’s Kyntheum (brodalumab), for plaque psoriasis; Chiesi Farmaceutici’s Trimbow (beclometasone dipropionate, formoterol fumarate dihydrate, and glycopyrronium), in chronic obstructive pulmonary disease; and Vifor Fresenius’ Veltassa (patiromer), for hyperkalemia.

The Spherox cell therapy was developed by CO.DON to repair cartilage defects in the knee. The CHMP also reviewed Dompé Farmaceutici’s orphan drug Oxervate (cenegermin) under accelerated assessment for the treatment of neurotrophic keratitis.

Zentiva’s generic version of Atripla — an HIV antiviral combination of efavirenz, emtricitabine, and tenofovir disoproxil — was also recommended for approval.

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