AstraZeneca and POZEN Inc. today announced that VIMOVO (naproxen/
esomeprazole magnesium) 500/20 mg modified-release tablets has cleared
an important regulatory milestone by receiving positive agreement for
approval in 23 countries across the European Union (EU). This follows
all 22 Concerned Member States agreeing with the assessment of the
Netherlands Health Authority (MEB), acting as the Reference Member State
for the Decentralised Procedure (DCP). It also results in a harmonised
Summary of Product Characteristics (SmPC). The Member States will now
pursue pricing and reimbursement and national approvals.
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.
VIMOVO, co-developed by AstraZeneca and POZEN Inc., is
a fixed-dose combination of enteric-coated naproxen, a pain-relieving
NSAID, and immediate-release esomeprazole, a proton pump inhibitor
(PPI). 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 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.
