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Amgen Puts Evenity Filing Back On Track With TIMI Cardiovascular Risk Review

 
• By Joseph Haas

As Amgen’s main hope for extending its bone health franchise, romosozumab faces a second review at the FDA with a fuller dataset and an external analysis of cardiovascular risk.

Osteoporosis upper limb bones - 3d rendering

Amgen Inc. and UCB Group have refiled the biologics license application (BLA) for their osteoporosis candidate Evenity (romosozumab) with a highly regarded study group’s review of the drug’s cardiovascular risk, hoping that will allay concerns that led to a complete response letter last July and which could limit the drug's competitive profile.

An evaluation of adverse event data by the Thrombosis in Myocardial Infarction (TIMI) study group at Brigham & Women’s Hospital is part of the refiled application, the partners announced July...

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