EU approves Vimovo

AstraZeneca/Pozen’s Vimovo (naproxen/ esomeprazole magnesium) 500/20 mg modified-release tablets, has cleared a regulatory milestone by receiving positive agreement for approval in 23 countries across the European Union (EU).

This follows all 22 concerned member states agreeing with the assessment of the Netherlands Health Authority (MEB), acting as the reference member state for the decentralised procedure (DCP). It also results in a harmonised summary of product characteristics (SmPC). The member states will now pursue pricing and reimbursement and national approvals.

Vimovo is indicated for the symptomatic treatment of osteoarthritis (OA), rheumatoid arthritis (RA), and ankylosing spondylitis (AS) in patients who are at risk for developing non-steroidal anti-inflammatory drug (NSAID)-associated gastric and/or duodenal ulcers and where treatment with lower doses of naproxen or of other NSAIDs is not considered sufficient.

Vimovo, co-developed by AstraZeneca and Pozen, is a fixed-dose combination of enteric-coated naproxen, a pain-relieving NSAID, and immediate-release esomeprazole, a proton pump inhibitor (PPI).

The positive agreement is based on a submission package including data from the pivotal 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.

“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 Lori Kreamer, global products vice president, AstraZeneca. “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 OA, which is the most common form of arthritis. While many patients with OA treat their symptoms with NSAIDs, 50 percent of chronic NSAID users are at risk of gastrointestinal ulcers.