AstraZeneca, POZEN Submit MAA In EU For VIMOVO

Published: 16-Oct-2009

VIMOVO is intended for the treatment of OA, RA and AS in patients who are at risk of developing NSAID-associated ulcers

AstraZeneca and POZEN have submitted a Marketing Authorisation Application (MAA) in the EU via the Decentralised Procedure (DCP) for VIMOVO (enteric-coated naproxen/immediate release esomeprazole magnesium, formerly known as PN 400) tablets. VIMOVO is a product under investigation for the treatment of the signs and symptoms of osteoarthritis (OA), rheumatoid arthritis (RA) and ankylosing spondylitis (AS) in patients who are at risk of developing NSAID-associated ulcers.

Reportedly, VIMOVO is a fixed-dose combination of enteric coated naproxen and immediate release esomeprazole under co-development by AstraZeneca and POZEN. Lori Kreamer, vice president of global product at AstraZeneca, said: “If approved, Vomovo may provide OA 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.”

POZEN has said that it had submitted a New Drug Application (NDA) to the FDA for VIMOVO in June 2009. The NDA was accepted on 31 August, 2009, and is currently under review.

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