European Union okays Vimovo for osteoarthritis, rheumatoid arthritis, and ankylosing spondylitis
Vimovo modified-release tablets received positive agreement for approval in 23 countries across the European Union.
Vimovo is distriubuted in the form of modified-release tablets as a fixed dose combination of 500 mg naproxen and 20 mg esomeprazole magnesium (a stomach acid-reducing proton pump inhibitor). It is indicated for the symptomatic treatment of osteoarthritis (OA), rheumatoid arthritis (RA), and ankylosing spondylitis (AS). It is to be used in patients who are at risk for developing non-steroidal anti-inflammatory drug (NSAID)-associated gastric and/or duodenal ulcers and in patients that experience insufficient relief from treatment with lower doses of naproxen or other NSAIDs.
The product is co-developed by AstraZeneca and Pozen, Inc., and is a fixed-dose combination of enteric-coated naproxen, a pain-relieving NSAID, and immediate-release esomeprazole, a proton pump inhibitor.
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 a press release. “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% of chronic NSAID users are at risk of gastrointestinal ulcers.
AstraZeneca submitted a Marketing Authorisation Application (MAA) in Europe via the DCP in the EU for VIMOVO on Oct. 15, 2009. The EU Concerned Member States that formed the DCP include: Austria, Belgium, Bulgaria, Czech Republic, Estonia, Finland, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, and the United Kingdom. Following this positive agreement, the Member States will now work to pursue pricing/reimbursement and national approvals.
On 30 April 2010, the US Food and Drug Administration (FDA) approved Vimovo for the relief of signs and symptoms of OA, RA, and AS, and to decrease the risk of developing gastric ulcers in patients at risk of developing NSAID-associated gastric ulcers.
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