AstraZeneca Submits Marketing Authorisation Application to European Union for VIMOVO
Fri, 10/16/2009 - 9:42am
AstraZeneca and POZEN Inc. today announced that they have submitted a Marketing Authorization Application (MAA) in the European Union via the Decentralised Procedure (DCP) for VIMOVO™ (enteric-coated naproxen/immediate release esomeprazole magnesium, formerly known as PN 400) tablets, 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. VIMOVO is a fixed-dose combination of enteric coated naproxen and immediate release esomeprazole under co-development by AstraZeneca and POZEN. “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 NSAID and PPI combination treatment after the third NSAID prescription,” said Lori Kreamer, Global Product Vice President, AstraZeneca. “If approved, VIMOVO 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.” In June 2009, POZEN submitted a New Drug Application (NDA) to the US Food and Drug Administration (FDA) for VIMOVO. The NDA was accepted on 31 August, 2009, and is currently under review.