AstraZeneca Submits NDA for Low Dose Aspirin/Esomeprazole Combinati...( - Company Also Submits sNDA for NEXIU...),Health

- Company Also Submits sNDA for NEXIUM Capsules for Risk Reduction of Low-Dose Aspirin-Associated Peptic Ulcer -

WILMINGTON, Del., May 4 /PRNewswire-FirstCall/ -- AstraZeneca (NYSE: AZN) today announced the submission of a new drug application (NDA) to the U.S. Food and Drug Administration (FDA) seeking approval for a product combining low dose aspirin with esomeprazole magnesium for the risk reduction of low dose aspirin-associated gastric and/or duodenal ulcers in patients at risk.

AstraZeneca also submitted a supplemental new drug application (sNDA) for NEXIUM(R) (esomeprazole magnesium) for the risk reduction of low dose aspirin-associated gastric and/or duodenal ulcers. NEXIUM already is approved for the risk reduction in the occurrence of gastric ulcers associated with continuous non-steroidal anti-inflammatory drug (NSAID) therapy in patients at risk for developing gastric ulcers.(1)

Low-dose aspirin is the mainstay in the prevention of cardio- and cerebrovascular events such as heart attack and stroke.(2A,3A) However, even at low doses, aspirin is associated with a risk of peptic ulcers and gastrointestinal symptoms.(3B,3C) These gastrointestinal side effects can lead patients to discontinue their aspirin therapy.(3D,3E) Discontinuation due to GI problems is associated with a three-fold higher risk of major CV events,(4A) which can occur within just 1-2 weeks of discontinuation.(4B) Up to 1 in 3 patients on low-dose ASA may develop upper GI symptoms.(5A,6A)

AstraZeneca conducted two studies to evaluate the safety and efficacy of NEXIUM in reducing the risk of gastric and/or duodenal ulcers in patients who take low dose aspirin (75-325 mg continuously during the study, which is defined as at least 5 days per week). One study compared NEXIUM 40 mg or 20 mg with placebo, while the oth
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