FDA Panel Backs Approval of Romosuzumab for Osteoporosis Save

The US Food and Drug Administration’s advisory committee on Bone, Reproductive and Urologic Drugs voted Wednesday in favor of approving Amgen’s osteoporosis anti-sclerostin drug, romosozumab (Evenity) for use women with postmenopausal osteoporosis. 

Reuters reports that the panel voted 16-1 in favor of the monthly injection developed jointly by UCB.

The FDA panel hearing was prompted by earlier studies that resulted in a July 2018 complete response letter for CV safety concerns. Panelists expressed concerns about the safety data, but nonetheless favored drug approval based on impressive efficacy data.  Most called for more post-marketing studies to further evaluate the long-term safety.

The FDA and sponsor presented data proving the effectiveness of romosozumab in postmenopausal osteoporosis, reducing vertebral fracture risk and trending towards a lower risk of non-vertebral fractures. 

Evenity, chemically known as romosozumab, belongs to a new class of drugs known as sclerostin inhibitors and is administered as a monthly subcutaneous injection. 

The FDA is not mandated to follow the recommendation of the panel, but generally does.

The meeting agenda, panel list and briefing documents can be found at the FDA website.