CHMP Gives Nod to 9 Drugs
The EMA’s Committee for Medicinal Products for Human Use is recommending approval of four new drugs, three biosimilars and two generics within the EU.
Among the drugs earning CHMP’s recommendation are two diabetes therapies: Novo Nordisk’s fast-acting insulin Fiasp and Sanofi’s fixed-ratio combination of insulin glargine, basal insulin and lixisenatide, Suliqua.
Csl Behring’s treatment for bleeding in patients with hemophilia, Afstyla, and Gilead Sciences’ therapy for chronic hepatitis B, Vemlidy, earned positive recommendations as well.
CHMP recommended the following biosimilars: Merck Sharp’s diabetes therapy Lusduna as well as two osteoporosis treatments, Stada Arzneimittel’s Movymia and Gedeon Richter’s Terrosa.
Two ofMylan’s generics — Darunavir Mylan, an HIV-1 infection treatment, and Tadalafil Generics, a hypertension medicine — received endorsements.