Seven Green Lights From EU’s CHMP, Including Drugs For Hemophilia, Diabetes, Alpha Mannosidosis And Hyperkalemia

The European Medicines Agency’s CHMP has OKd seven new products, including drugs for hemophilia A, diabetes, alpha mannosidosis, hyperkalemia and herpes zoster. But it again rejected Santhera’s filing for Raxone in the new indication of Duchenne muscular dystrophy, and also turned down Repros’ Encyzix for hypogonadism.

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The EU's CHMP OKd seven new products this week.

The European Medicines Agency’s key scientific committee, the CHMP, this week recommended approval of seven products, the same number as in December 2017. They include Roche’s Hemlibra (emicizumab) for hemophilia A, Chiesi Farmaceutici’s orphan drug Lamzede (velmanase alfa) for alpha mannosidosis, and GlaxoSmithKline PLC’s Shingrix, a vaccine for herpes zoster.

At its first monthly meeting of 2018, the CHMP also confirmed its earlier positive opinion on AstraZeneca PLC’s Lokelma (sodium zirconium cyclosilicate) for hyperkalemia, and recommended approval of another biosimilar version of

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