Semaglutide's CHMP Backing Stipulates Post-Approval Safety Studies
Novo Nordisk's once-weekly diabetes treatment semaglutide wins backing from EMA's top advisory panel one week after the GLP-1 agonist was approved in the US, the first country to do so. Safety studies have been required.
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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.
A new ATMP, two generics and a biosimilar got the thumbs up this week from the European Medicines Agency’s drug evaluation committee, the CHMP. The committee also recommended one product for conditional authorization and another for a pediatric use authorization, But it turned down a potential multiple myeloma therapy derived from sea squirts.
Highly positive top-line weight loss results for Novo Nordisk's new GLP-1 agonist semaglutide are propelling it into Phase III trials next year for the notoriously tricky indication. The product is currently under review for type 2 diabetes.