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Amgen and UCB’s Evenity finally approved, but with label warnings

Drug unlikely to match Prolia's revenues

Amgen and UCB’s novel osteoporosis treatment Evenity has been approved by the FDA, nearly two years after it was first submitted.

Evenity (romosozumab) is a first-in-class antibody treatment that builds bone in postmenopausal women with osteoporosis at high risk for fracture, with trials showing it to be superior to standard treatment Fosamax in reducing vertebral and non-vertebral fractures.

However, the drug comes with some cardiovascular safety risks, and it is these that have delayed its arrival on the market, and subsequent label warnings are certain to limit its use.

Additional data from the FRAME trial helped change the FDA’s mind at the second time of asking, securing what is a major new product approval for Amgen and UCB.

Amgen needs a successor to its $2bn a year osteoporosis blockbuster Prolia (denosumab), which is approaching patent expiry - however Evenity looks unlikely to match its predecessor’s performance.  Analysts at Jefferies recently predicted sales of around $500m a year for the drug.

Evaluate Pharma forecast that this will translate into $206m for Amgen’s share of the sales by 2024.

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.

Evenity also carries a boxed warning on its label, which advises that the drug may increase the risk of heart attack, stroke and cardiovascular death.

Hylton Joffe

The CDER's Hylton Joffe

“Today’s approval provides women with postmenopausal osteoporosis who are at high risk of fracture with a new treatment that will reduce this risk,” said Hylton V. Joffe, director of the FDA’s CDER Division of Bone, Reproductive and Urologic Products.

“But Evenity may increase the risk of heart attack, stroke and cardiovascular death so it’s important to carefully select patients for this therapy, which includes avoiding use in patients who have had a heart attack or stroke within the previous year.”

The label also notes that doctors should consider whether the benefits outweigh the risks in patients with other cardiovascular risk factors, and if a patient experiences a heart attack or stroke during therapy, treatment with Evenity should be discontinued.

Nevertheless, with its patient-friendly once-monthly dosing regimen and strong efficacy profile, some analysts believe Evenity can become the market leader within five years. This would see it overtake Radios' Tymlos, which hit the market in 2017, but has enjoyed less than stellar sales.

Amgen’s R&D head David Reese welcomed the FDA approval, and said postmenopausal osteoporosis was a significant women's health issue that “far too often” gets overlooked.

"One in two women will experience a fracture due to osteoporosis in her lifetime. These fractures can be devastating, with many leading to hospital stays and life-altering consequences," he adds.

The companies say Evenity will be available from next week in the US, at which point its price will be disclosed.

Article by
Andrew McConaghie

10th April 2019

From: Marketing



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