AstraZeneca files for aspirin/esomeprazole

The US unit of Anglo-Swedish drug major AstraZeneca has submitted a New Drug Application to the Food and Drug Administration 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 filed a supplemental NDA for Nexium (esomeprazole  magnesium) for the risk reduction of low-dose aspirin-associated gastric  and/or duodenal ulcers. Nexium, which earned the drugmaker $1.19 billion  in first-quarter 2009, is already approved for the risk reduction in  the occurrence of gastric ulcers associated with continuous  non-steroidal anti-inflammatory drug therapy in patients at risk for  developing gastric ulcers.

Low-dose aspirin is the mainstay in the prevention of cardio- and  cerebrovascular events such as heart attack and stroke. However, even at  low doses, aspirin is associated with a risk of peptic ulcers and  gastrointestinal symptoms. These GI side effects can lead patients to  discontinue their aspirin therapy. Stopping due to GI problems is  associated with a three-fold higher risk of major CV events, which can  occur within just one-two weeks of discontinuation. Up to one in three  subjects on low-dose ASA may develop upper GI symptoms.