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Evenity Gets CHMP Nod On Second Pass

UCB/Amgen Osteoporosis Drug Will Still Face Market Challenges

 
• By Eleanor Malone

UCB and Amgen’s osteoporosis drug Evenity has been given a positive opinion in Europe after initial rejection. But cardiovascular safety concerns and rival products constrain sales potential.

Osteoporosis
Evenity recommende for severe osteoporosis

UCB Group has secured a green light in the EU for the osteoporosis drug Evenity (romosozumab). Winning over the European Medicines Agency’s Committee for Medicinal Products for Human Use after it issued a negative opinion in June is a boon for the Belgian firm, which is responsible for sales in Europe, and its partner Amgen Inc.. However, commercial success is by no means assured.

Following a re-examination hearing which included advice from patient representatives and experts in osteoporosis and cardiovascular disease, the CHMP on 18 October decided to recommend market authorization but to restrict its use to postmenopausal women with more severe disease (low bone density and a previous fracture) at high risk of fracture and without a history of heart attack or stroke. It is to be given as a monthly subcutaneous injection for one year

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