AstraZeneca and Pozen have co-developed Vimovo, which is a fixed-dose combination of enteric-coated naproxen, a pain-relieving NSAID and immediate-release esomeprazole, a proton pump inhibitor (PPI).
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.
AstraZeneca and Pozen said that 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.
AstraZeneca Global Products vice president Lori Kreamer said that the support for the approval of Vimovo in Europe is a significant milestone, which they believe would provide a new treatment option for the arthritis patients in the EU at risk for NSAID-associated ulcers.
"In one tablet, Vimovo offers the proven pain relief of naproxen with built-in ulcer risk reduction," Kreamer said.