It was good news for AstraZeneca and partner Pozen on Friday after regulators across the Atlantic issued a green light for the new combination arthritis drug Vimovo, which also reduces the risk of developing stomach ulcers.
Specifically, the US Food and Drug Administration has approved the use of Vimovo (naproxen and esomeprazole magnesium) to alleviate the signs and symptoms of osteoarthritis, rheumatoid arthritis and ankylosing spondylitis, as well as decrease the risk of developing gastric ulcers in patients prone to NSAID-associated gastric ulcers.
The drug is a fixed-dose combination of delayed-release enteric-coated naproxen, an NSAID analgesic, and the proton pump inhibitor esomeprazole (AstraZeneca’s blockbuster antiulcerant Nexium), which is designed to address the problem that half of chronic NSAID users – such as patients with arthritis – go on to develop stomach ulcers.
In clinical trials the agent has clearly shown its ability to tackle the symptoms of arthritis as well as slash the ulcer risk, with data from one study showing a 4.1% incidence of gastric ulcers in patients taking Vimovo compared to 23.1% among patients taking enteric-coated naproxen alone.
All eyes will now be on the European Medicines Agency, which is currently assessing the firms’ marketing application on this side of the pond following its submission last October.
