FDA Rejects Amgen-UCB Osteoporosis Candidate Evenity

Modesto Morganelli
Luglio 18, 2017

By filing the three studies together, Amgen and UCB hope to show that Evenity has an overall positive risk-benefit profile.

The FDA has rejected Amgen and UCB's Evenity (romosozumab) osteoporosis drug after a late-stage trial unexpectedly highlighted a potential cardiac safety risk.

Amgen said the agency has issued a complete response letter for the Evenity biologics license application (BLA) asking that efficacy and safety data from the ARCH study be integrated into the application.

As expected, the USA 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.

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. The companies said treatment with the sclerostin-targeting monoclonal antibody (mAb) for 12 months followed by alendronate significantly reduced the incidence of new vertebral fractures through 24 months, as well as clinical fractures and nonvertebral fractures in postmenopausal women with osteoporosis at high risk for fracture, compared to alendronate alone.

"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. (2) The concern is in the recent ARCH data (4000 pts) in May, an imbalance in positively adjudicated cardiovascular serious adverse events was observed as a new safety signal (2.5% vs 1.9% alendronate at 12 mos).

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.

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