AstraZeneca and partner Pozen have announced this morning that their pain drug Vimovo has been approved in the European Union.
Vimovo, a combination of the Anglo-Swedish drugmaker’s antiulcerant Nexium (esomeprazole) and the anti-inflammatory naproxen, has been given the green light for the symptomatic treatment of osteoarthritis, rheumatoid arthritis and ankylosing spondylitis. Specifically it can be used in patients who are at risk for developing non-steroidal anti-inflammatory drug-associated gastric and/or duodenal ulcers and where treatment with lower doses of naproxen or of other NSAIDs is not considered sufficient.
The European approval comes almost six months after the US Food and Drug Admniistration approved the combo. The thumbs-up is based on a submission package including data from two late-stage trials, PN400-301 and PN400-302, which demonstrated that patients taking Vimovo experienced significantly fewer endoscopic gastric ulcers, compared to patients receiving enteric-coated naproxen.
Lori Kreamer, vice president of global products at Astraeneca, said the approval "is a significant milestone, which we believe will provide a new treatment option for the millions of arthritis patients in the EU at risk for NSAID-associated ulcers". Analysts believe that Vimovo will have peak sales of $500-$700 million.