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CHMP says OK to UCB/Amgen’s Evenity for osteoporosis after appeal

Initially received a negative opinion of the drug


The EMA’s main advisory committee has changed its position on UCB and Amgen’s application for their severe osteoporosis drug Evenity, recommending it for approval.

The Committee for Medicinal Products for Human Use (CHMP) issued a negative opinion on first-in-class antibody Evenity (romosozumab) in June, but re-examined the drug after an appeal by its developers.

Now, it has backed Evenity – an anti-sclerostin antibody that works by building new bone – for the treatment of severe osteoporosis in postmenopausal women at high risk of fracture.

UCB and Amgen now say they are hoping for an EMA approval before the end of the year, which will come after approvals for Evenity in the US and Japan earlier this year.

It has been a long and arduous road to registration for the new drug however, with the approvals coming three years after it was first filed for approval in 2016 having been held up by regulator concerns about its cardiovascular safety.

In the US it was cleared with a warning on the label that it may increase the risk of heart attack, stroke and cardiovascular death however, prompting analysts at Jefferies to predict its sales will be held back to around $500m, despite earlier blockbuster projections.

The CHMP’s recommendation is for use of the drug in patients with no history of myocardial infarction or stroke, a narrower indication than originally anticipated

In its favour, Evenity has a patient-friendly once-monthly dosing regimen and strong efficacy in preventing fractures, but its delay to market also allowed another bone-building osteoporosis therapy – Radius Health’s Tymlos (abaloparatide) – to reach the market first.

Tymlos has started to gather momentum with sales predicted to reach around $170m this year, according to Radius.

Amgen in particular needs a successor to its $2bn a year osteoporosis blockbuster Prolia (denosumab), which is approaching the end of its patent life, but with the delays and restrictions Evenity is looking unlikely to fill that void.

UCB executive vice president Dr Pascale Richetta said however that new treatment options are still badly needed for these patients.

“Post-menopausal osteoporosis and fragility fractures are a significant women’s health issue that’s far too often overlooked, with evidence showing that an estimated 77% of women aged 67 or older remain undiagnosed and untreated following a fracture,” she pointed out.

For UCB, the CHMP’s volte-face is a second bit of positive news this week, coming after it reported the first phase 3 data for its psoriasis antibody bimekizumab, which showed it was better at clearing skin than placebo and Johnson & Johnson’s big-selling Stelara (ustekinumab) product.

Bimekizumab is one of the top prospects in the Belgian drugmaker’s pipeline as it faces patent expiries on key brands in the next few years, although data will have to very impressive as competition is increasingly fierce among biological therapies for psoriasis.

Article by
Phil Taylor

18th October 2019

From: Regulatory



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