FDA Requires More Data on Proposed Osteoporosis Drug Evenity

Evrard Martin
Juillet 17, 2017

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.

The original application, submitted to the FDA in September 2016, was based on efficacy and safety data from the phase 3 placebo-controlled Fracture Study in Postmenopausal Women with Osteoporosis (FRAME) conducted in almost 7,200 women.

Last year, the drug hit its main target of reducing vertebral fractures in the FRAME study, but was unable to reduce non-vertebral fracture, a key secondary endpoint. Then in May the ARCH trial showed a reduction in both vertebral and non-vertebral fractures - albeit with a much stronger effect on the former - but also revealed that more patients on romosozumab than the comparator drug (alendronate) had cardiovascular side effects.

"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, MD, executive vice president of Research and Development at Amgen. He also pointed out that Amgen plans to invest more time towards understanding the risk and benefit profile of EVENITY. 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.

While anticipated the delay to romosozumab is more good news for Radius Health, which claimed United States approval for its Tymlos (abaloparatide) drug for osteoporosis in April on the strength of robust data, including an 86% reduction in new vertebral fractures and a 43% cut in non-vertebral fractures. Jesper Høiland, previously the president of Novo Nordisk Inc. Ward had held the position since 2013 and steered the company through obtaining regulatory approval for Tymlos as well as raising more than $750 million in private and public financings, including the company's 2014 IPO.

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