Amgen has received a Complete Response Letter for the Biologics License Application from the FDA asking the company to add safety and efficacy data from the ARCH and BRIDGE studies into the drug application for romosozumab as a treatment for postmenopausal women with osteoporosis, according to a company press release. So since neither of these studies are powered to show significant differences in CV events and preclinical and genetic data hasn't suggested anything target related, it would seem to be just a numerical imbalance and bad luck and if the two studies were pooled, unlikely to see any major difference either (math suggests pooling takes it to 0.89% vs 0.68% control) (3) Per AMGN, they believe there is strong efficacy here (ARCH hit both vertebral and nonvertebral endpoints), but safety is a barrier, and they will have to find the right patients to treat.
The FDA was already reviewing a filing based on the FRAME study, but the companies will now have to refile including results from ARCH, and the as-yet unannounced BRIDGE study evaluating osteoporosis in men. The original submission included data from the pivotal phase 3 placebo-controlled FRAME study of postmenopausal women with osteoporosis, but data from the phase 3 active-comparator ARCH study is now available. "We look forward to working through the review process with the agency", said Sean E. Harper, MD, executive vice president of Research and Development at Amgen.
"We remain committed to helping patients with osteoporosis and will use the additional time to better understand the benefit:risk profile of Evenity".
Dr. Pascale Richetta, head of bone and executive vice president, UCB, said: "The reality is that once a woman has a fragility fracture, she is five times more likely to suffer another within a year". This is reason enough for more efforts towards reducing the risks of disabling and painful fractures in the future as well as improving post-fracture care. This represents the commitment that Amgen and UCB have towards coming up with new treatment for those at risk of fragility fractures.
Amgen stock closed the latest trading session on Friday at $117.13.