AstraZeneca, Pozen Clear E.U. Approval Hurdle for Arthritis Drug Vimovo

AstraZeneca (AZN) and Pozen (POZN) announced Monday that that their Vimovo modified-release pain reliever tablets for the treatment of osteoarthritis, rheumatoid arthritis and ankylosing spondylitis had received positive agreement for approval across 23 countries in the European Union.

Many patients who suffer from these chronic conditions affecting the joints take pain relievers in the class known as NSAIDs (non-steroidal anti-inflammatory drugs). But while NSAIDs do relieve the symptoms, they put long-term users at risk of developing gastrointestinal ulcers. Vimovo aims to reduce such risks because it combines the NSAID naproxen with esomeprazole magnesium, which reduces the production of gastric acid.

In trials, patients taking Vimovo experienced significantly fewer endoscopic gastric ulcers, compared to patients receiving naproxen alone, AstraZeneca said in a statement.

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The drug is indicated for the treatment of those patients who are at risk for developing certain NSAID-associated ulcers and where treatment with lower doses of naproxen or of other NSAIDs is not considered sufficient.

"This support for the approval of Vimovo in Europe 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," said Global Products VP Lori Kreamer. "In one tablet, Vimovo offers the proven pain relief of naproxen with built-in ulcer risk reduction."

Nearly 151 million people worldwide and approximately 28 million people in Europe suffer from osteoarthritis, which is the most common form of arthritis, according to the companies.

Pozen shares were up 7.7% in premarket trading Monday, while AstraZeneca shares were up 0.6% in London.