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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...

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