AstraZeneca Submits NDA for Aspirin/Nexium Product


AstraZeneca submitted an NDA to the FDA seeking approval for low-dose aspirin combined with esomeprazole magnesium (Nexium) to reduce the risk of low-dose aspirin-associated side effects, such as gastric and/or duodenal ulcers.

AstraZeneca also submitted a sNDA for Nexium for the risk reduction of low-dose aspirin-associated gastric and/or duodenal ulcers. Nexium is approved for the risk reduction of gastric ulcers associated with continuous non-steroidal anti-inflammatory drug (NSAID) therapy in patients at risk for developing ulcers.

Low-dose aspirin is used for the prevention of cardio- and cerebrovascular events such as heart attack and stroke. However, low-dose aspirin is associated with a risk of peptic ulcers and gastrointestinal symptoms.

Both of the submissions are based on the results of two studies evaluating the safety and efficacy of Nexium in reducing the risk of gastric and/or duodenal ulcers in patients who take low dose aspirin. One study compared Nexium 40 mg or 20 mg with placebo, while the other study compared Nexium 20 mg with placebo.