Pharmaceutical companies Amgen and UCB have received a Complete Response Letter from the US Food and Drug Administration (FDA) for Evenity, a treatment for postmenopausal women with osteoporosis.
The original Biologics License Application (BLA) included data from the Phase III placebo-controlled FRAME study (fracture study in postmenopausal women with osteoporosis).
The FDA has asked the companies to provide efficacy and safety data based on a Phase III active-comparator ARCH study (active-controlled fracture study in postmenopausal women with osteoporosis at high risk of fracture).
The resubmission of the BLA will also include a BRIDGE study (placebo-controlled study evaluating the efficacy and safety of romosozumab in treating men with osteoporosis).
Amgen research and development executive vice-president Sean Harper said: “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.
“We look forward to working through the review process with the agency.”
Evenity is an investigational bone-forming monoclonal antibody used to treat osteoporosis that is yet to be approved by a regulatory authority.
It has been designed to prevent sclerostin activity to rapidly increase bone formation and reduce bone resorption simultaneously.
Evenity has been studied under two large fracture trials that compared the antibody with placebo or an active comparator in more than 10,000 postmenopausal women with osteoporosis.
UCB executive vice-president Dr Pascale Richetta 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 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."
Under a collaboration and licence agreement signed in 2004, Amgen and UCB have been working together to research, develop and market antibody products, including Evenity.