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CHMP Recommends 13 New Drugs for Approval, Including Two Orphan Meds

May 3, 2019

The EMA’s Committee for Medicinal Products for Human Use (CHMP) flagged 13 medicines for approval at its April meeting, including two orphan medications and a biosimilar.

The two orphan drugs—Novo Nordisk’s Esperoct (turoctocog alfa pegol) and Alexion’s Ultomiris (ravulizumab)—received positive opinions for preventing bleeding in hemophilia A patients 12 years and above and paroxysmal nocturnal hemoglobinuria in adults, respectively.

USV’s biosimilar Talzenna (talazoparib) snagged a positive opinion for preventing neutropenia in adults treated with cytotoxic chemo.

The committee also recommended: Dova’s Doptelet (avatrombopag) for severe thrombocytopenia; Viiv Healthcare’s Dovato (dolutegravir/lamivudine) for treating HIV; Evolus’ Nuceiva (botulinum toxin type A) for improving glabellar lines; Pfizer’ Talzenna (talazoparib) for breast cancer; GSK’s Temybric Ellipta (fluticasone furoate/umeclidinium/vilanterol) for maintenance treatment of COPD; and Nova Laboratories’ Xromi (hydroxycarbamide), a hybrid medication for preventing complications from sickle cell anemia.

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