Therapy Areas: Cardiovascular
Amgen & UCB wins the US FDA BRUDAC's recommendation for approval of EVENITY for treating osteoporosis in postmenopausal women
17 January 2019 -

Human therapeutics company Amgen (NASDAQ:AMGN) and UCB (Euronext Brussels:UCB) on Wednesday jointly announced the US Food and Drug Administration (FDA) Bone, Reproductive and Urologic Drugs Advisory Committee's (BRUDAC) recommendation for the approval of EVENITY (romosozumab) for treating osteoporosis in postmenopausal women.

The companies added 18 of 19 members voted in favour of the approval of EVENITY (romosozumab) for treating postmenopausal women with osteoporosis at high risk for fracture based on the review of the safety and efficacy data from the pivotal Phase 3 studies. The committee emphasized the need for post-marketing follow-up.

This Phase 3 EVENITY development programme includes 19 clinical studies that enrolled 14,000 patients. The studies include FRAME, a placebo-controlled study with 7,180 postmenopausal women with osteoporosis at risk for fracture; ARCH, an active comparator-controlled study with 4,093 postmenopausal women with osteoporosis and with prior history of fracture; as well as STRUCTURE, an active comparator-controlled study with 436 postmenopausal women with osteoporosis, said the company.

The BRUDAC evaluated the FRAME and ARCH studies in its review of the clinical benefit:risk profile of EVENITY, including the cardiovascular safety finding seen in the ARCH study, for the potential to reduce the risk of fractures and increase bone mineral density (BMD) in postmenopausal women with osteoporosis.

EVENITY is an investigational bone-forming monoclonal antibody. It is designed to work by inhibiting the activity of sclerostin, which enables EVENITY to rapidly increase bone formation and reduce bone resorption simultaneously. Amgen and UCB are co-developing EVENITY.

Worldwide, one in three women and one in five men, over the age of 50, will suffer a fragility fracture due to osteoporosis and with an aging population these numbers will rise.

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