FDA refuses approval of Amgen osteoporosis drug

Amgen and its development partner UCB have announced that the FDA has issued a complete response letter for the biologics license application for their osteoporosis drug Evenity (romosozumab), refusing to approve the treatment for use in postmenopausal female patients.

The US regulator has instead requested that Amgen submit data from the late-stage Bridge and Arch trials as part of the current marketing application in order to better support the case for Evenity’s efficacy and safety. Arch examined 4,093 postmenopausal women with osteoporosis at high risk of fracture, treating them with Evenity for 12 months, followed by 12 months of alendronate treatment. Bridge looked at 245 men aged 55-90 with the disease and a history of fragility or vertebral fracture.

As a result of the FDA’s decision, Evenity’s application could be significantly delayed, meaning rival Radius Health will have free reign in the market with its newly approved drug Tymlos (abaloparatide) in the meantime.    

The news was not unexpected, and while the drug hit its primary endpoints earlier this year, it also flagged alarming cardiovascular risks. This latest delay has many worried over the future of the treatment, and whether it will make it to market at all; it is due for resubmission with the additional data as an extension of the existing review.  

"During our interactions with the FDA, we agreed that the Arch data should be considered in the regulatory review prior to the initial marketing authorisation and, as a result, anticipated this request," explained Sean E Harper, Executive Vice President of Research and Development at Amgen.  "We look forward to working through the review process with the Agency. We remain committed to helping patients with osteoporosis and will use the additional time to better understand the benefit:risk profile of Evenity."