AstraZeneca and Pozen file European MAA for arthritis drug

Mon. October 19, 2009; Posted: 01:11 PM

Oct 19, 2009 (Datamonitor via COMTEX) -- POZN | Quote | Chart | News | PowerRating -- AstraZeneca, a UK-based pharmaceutical company, and Pozen, a US-based pharmaceutical company, have submitted a marketing authorization application or MAA in the EU via the decentralized procedure for Vimovo tablets, a product under investigation for the treatment of the signs and symptoms of osteoarthritis, rheumatoid arthritis and ankylosing spondylitis in patients who are at risk of developing non-steroidal anti-inflammatory drug-associated ulcers.

Vimovo is a fixed-dose combination of enteric coated naproxen and immediate release esomeprazole under co-development by AstraZeneca and Pozen.

In June 2009, Pozen submitted a new drug application (NDA) to the FDA for Vimovo. The NDA was accepted on August 31, 2009, and is currently under review.

Lori Kreamer, global product vice president of AstraZeneca, said: "Nearly 151 million people worldwide suffer from osteoarthritis. However, up to one third of osteoarthritis patients change therapy in a year, primarily due to lack of pain-relieving efficacy, and 60% of patients do not continue to adhere to an non-steroidal anti-inflammatory drug (NSAID) and proton pump inhibitor combination treatment after the third NSAID prescription.

"If approved, Vimovo may provide osteoarthritis patients at risk of NSAID-associated ulcers a new treatment option that offers both enteric coated naproxen and immediate release esomeprazole in a single pill."

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