Amgen and UCB's application to market bone-boosting drug Evenity as a treatment for postmenopausal women with osteoporosis has hit a setback, having been turned down by USA regulators. Radius said on April 28 that the FDA approved Tymlos for postmenopausal women with osteoporosis at high risk for fracture defined as history of osteoporotic fracture, multiple risk factors for fracture, or patients who have failed or are intolerant to other available osteoporosis therapy.
The US Food and Drug Administration has issued a Complete Response Letter asking for new safety and efficacy data from the Phase III active-comparator ARCH study to be integrated into the drug's submission, to build on that included in the original filing taken from the Phase III placebo-controlled FRAME study.
As expected, the United States regulator wants to see data from the recently-completed ARCH trial of the anti-sclerostin antibody added into the marketing application, along with the results of the BRIDGE study in men with osteoporosis, which means the application will have to be re-filed.
"During our interactions with the FDA, we agreed that the ARCH data should be considered in the regulatory review prior to the initial marketing authorization and, as a result, anticipated this request. We look forward to working through the review process with the Agency", said Sean E. Harper, M.D., evp of R&D at Amgen. He also pointed out that Amgen plans to invest more time towards understanding the risk and benefit profile of EVENITY.
"The reality is that once a woman has a fragility fracture, she is five times more likely to suffer another within a year", Pascale Richetta, MD, head of bone and executive vice president at UCB, said in the release. "This is a stark reminder that there is an urgent need to improve post-fracture care and reduce the risk of painful, disabling fractures in the future".
Dr. Richetta also pointed out that the three Phase 3 clinical trials of the treatment have collected data from more than 11.000 patients. This represents the commitment that Amgen and UCB have towards coming up with new treatment for those at risk of fragility fractures.