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UCB/Amgen’s Evenity finally cleared for osteoporosis in Europe

First new drug for the disease in the EU since 2010


UCB and Amgen have finally claimed European approval for their osteoporosis drug Evenity, which becomes the first new drug for the disease in the EU since 2010.

Anti-sclerostin antibody Evenity (romosozumab) – which works by increasing bine formation and reducing bone loss – has been cleared by the regulator for the treatment of severe osteoporosis in postmenopausal women at high risk of fracture.

The green light comes after a long haul through the regulatory channel for Evenity, which was first filed in the US in 2016 on the strength of the FRAME study, which showed impressive activity in reducing fracture rates and improving bone mineral density in postmenopausal women with osteoporosis.

A second trial called ARCH was also positive but raised some concerns about Evenity’s cardiovascular safety, which led to a rejection by the FDA in 2017 and held up approval until earlier this year.

The FDA only gave the go-ahead to the drug with a label warning that it may increase the risk of heart attack, stroke and cardiovascular death, prompting analysts at Jefferies to predict that would limit its use and restrict sales to around $500m.

In Europe, an EMA advisory committee turned down Evenity in June, before reversing its opinion in October after a re-examination of the data at the request of Amgen and UCB. The EMA approval also includes wording indicating that serious cardiovascular events are an important identified risk.

UCB’s head of patient value unit bone and executive vice president Dr Pascale Richetta said Europe’s ageing population means osteoporosis is a growing problem and needs new treatment options.

“Fragility fractures, due to osteoporosis, affect one in three women aged over 50, and evidence shows that many women remain undiagnosed and untreated following a fracture,” she pointed out. “With today’s approval of romosozumab we can now offer patients and clinicians a new medicine that can help drive positive changes in secondary fracture prevention.”

Amgen needs a successor to its $2bn a year osteoporosis blockbuster Prolia (denosumab), which is approaching the end of its patent life – and while Evenity’s approval is step towards that goal analysts say it is unlikely to fill the void with its current labeling.

The first launches of romosozumab in the European Economic Area (EEA) are planned for the first half of 2020, according to UCB.

Article by
Phil Taylor

12th December 2019

From: Regulatory



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