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

Executive Summary

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 Italian group has got the green light in Europe for Lamzede, the first disease-modifying therapy for alpha mannosidosis and believes the drug, along with Procysbi and an investigational Fabry disease being developed with Protalix, constitute a strong portfolio in the rare metabolic disease area.

Seven New Drugs Approved In EU In First Two Months of 2018

Seven products containing a new active substance were approved in Europe in the first two months of 2018: Shire's Adynovi and Roche/Chugai's Hemlibra for hemophilia A, Roche's Ocrevus for multiple sclerosis, Kyowa Kirin's Crysvita for hypophosphatemia, AstraZeneca's Fasenra for asthma, Novo Nordisk's Ozempic for diabetes, and MSD's Prevymis for prophylaxis of cytomegalovirus infection.

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Bristol-Myers Squibb’s decision to withdraw its EU application to extend Opdivo’s use to metastatic colorectal cancer (mCRC) follows a similar move for liver cancer last year. The company now seems to be more interested in pursuing the product’s use in combination with Yervoy and Mekinist in mCRC.

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