FDAnews Drug Daily Bulletin
Pharmaceuticals / Regulatory Affairs

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

May 6, 2019
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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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