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Evenity back on track with FDA panel blessing in osteoporosis

US drugs regulator first rejected the drug due to cardiovascular concerns


Amgen and UCB’s long path to US approval of osteoporosis drug Evenity finally seems to be nearing an end, with an FDA panel voting in favour of the drug yesterday.

While the FDA still has the final say on full approval, the bone-building drug seems to have finally shaken off the cardiovascular safety concerns that caused the agency to reject Amgen’s first marketing application back in 2017. The panel backed the use of the drug in postmenopausal women with osteoporosis at high risk for fracture by 18-1.

Amgen has already secured its first marketing approval for Evenity (romosozumab) – in Japan earlier this month – and with US approval seemingly assured now has the successor it needs for its $2bn blockbuster osteoporosis biologic Prolia (denosumab) which is in the last few years of its patent life.

Evenity is an anti-sclerostin antibody which works by blocking a pathway that inhibits bone growth, resulting in increased bone formation and decreased bone breakdown. It works in a very different way to existing drugs like bisphosphonate alendronate – sold by Merck/MSD as Fosamax – which works only by blocking bone destruction.

In the ARCH trial, Evenity showed a reduction in both vertebral and non-vertebral fractures compared to alendronate - albeit with a much stronger effect on the former - but was also linked to a much higher risk of cardiovascular side effects than the comparator drug.

Amgen gambled on another, much larger phase 3 trial called FRAME to resurrect the programme and that – coupled with the BRIDGE study in 245 men with osteoporosis – found that the cardiovascular risk was lower than suggested by the ARCH data, whilst backing up Evenity’s efficacy in preventing fractures.

Importantly for Amgen, FDA briefing documents published ahead of the advisory committee meeting also took a neutral tone on the drug’s safety, and with Japan’s regulators also happy with its risk:benefit profile the odds look good for approvals around the world. Analysts at Jefferies recently predicted sales of around $500m a year for the drug if approved in the US, noting that it could still have warning on its label about cardiovascular risk.

Amgen’s R&D head Davide Reese said that having additional treatment options for postmenopausal women with osteoporosis is important, as “a fracture due to osteoporosis can be devastating to the lives of patients.”

David Reese

David Reese, executive vice president, R&D, Amgen

“After an osteoporotic fracture, a woman is five times more likely to suffer another fracture within the first year, and her risk remains elevated over time if untreated,” he pointed out.

In the US, 50% of women over the age of 50 will experience an osteoporotic fracture, but only 20% of women with fractures receive any type of osteoporosis treatment in the first year.

Amgen and UCB are co-developing Evenity worldwide, with development in Japan being led by an Amgen/Astellas joint venture. The drug is currently under regulatory review in Europe.

The closest direct rival to Evenity so far was an anti-sclerostin antibody developed by Eli Lilly called blosozumab, but that has been plagued by formulation issues and no longer appears in the company’s latest pipeline update.

Article by
Phil Taylor

17th January 2019

From: Research, Regulatory



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