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Amgen/UCB To Appeal EMA’s 'Over Cautious' Evenity Rejection

 
• By Vibha Sharma and Maureen Kenny

Amgen and UCB say that the European Medicines Agency’s re-examination process should allow them to clarify their position on the data supporting the marketing authorization application for their osteoporosis drug, Evenity. Meanwhile, three other drugs received a positive opinion from the EMA this week for pan-EU approval, including La Jolla’s Giapreza.

Osteoporosis upper limb bones - 3d rendering
Evenity Is Approved In The US With A Black Box Warning • Source: Shutterstock

Amgen and UCB will ask the European Medicines Agency to re-examine its decision to recommend against EU-wide marketing approval of their osteoporosis drug, Evenity (romosozumab). The drug is already authorized for use in the US and several other countries.

Serious cardiovascular safety concerns prompted the EMA's drug evaluation committee, the CHMP, to recommend against EU approval of the marketing...

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