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FDA approves AstraZeneca/Pozen's pain drug Vimovo

World News | May 01, 2010


Kevin Grogan

AstraZeneca and partner Pozen are celebrating after regulators in the USA gave the green light for Vimovo to be used in patients with arthritis who are at risk of developing gastric ulcers.

Specifically the US Food and Drug Administration has approved Vimovo, a combination of the Anglo-Swedish drugmaker’s antiulcerant Nexium and the anti-inflammatory naproxen, for treating the symptoms of osteoarthritis, rheumatoid arthritis and ankylosing spondylitis in patients at risk of developing ulcers from taking non-steroidal anti-inflammatory drugs. The FDA approval was principally supported by data from two studies, called PN400-301 and PN400-302.

In the first of those studies, the data showed a 4.1% incidence of gastric ulcers in patients taking Vimovo, compared to 23.1% among patients taking enteric-coated naproxen, while PN400-302 revealed a 7.1% incidence of ulcers among patients taking the newly-approved, compared to 24.3%.

Howard Hutchinson, chief medical officer at AstraZeneca, said that "in a single pill, Vimovo provides a proven pain reliever with a built-in proton pump inhibitor for arthritis patients at-risk for NSAID-associated gastric ulcers”. The US approval has triggered a $20 million milestone payment to Pozen and it comes some six months after the combo was filed with regulators in Europe.

Analysts predict that Vimovo could bring in $500 million in peak sales. The companies noted that 27 million Americans are affected by osteoarthritis, and while many patients treat their symptoms with NSAIDs, 50% of chronic NSAID users are at risk of developing gastrointestinal ulcers.

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