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FDA issues complete response letters for Axanum NDA, Nexium sNDA
Friday, June 04 2010 | Comments
What's This?
The Food and Drug Administration sent 2 complete response letters to AstraZeneca Plc regarding the firm's New Drug Application (NDA) for the fixed-dose combination agent Axanum (aspirin/esomeprazole magnesium) and its supplemental NDA for Nexium (esomeprazole magnesium).The company is seeking approval of Axanum to reduce the risk of low-dose aspirin-associated gastric and/or duodenal ulcers in patients who are at risk. It is also seeking supplemental approval of Nexium to reduce the risk of low-dose aspirin-associated peptic ulcers.
Both applications, which were submitted in April 2009, were supported by results from 2 placebo-controlled trials that evaluated the safety and efficacy of Nexium in reducing the risk of gastric and duodenal ulcers in patients who were taking low-dose aspirin therapy (75 mg/day to 325 mg/d continuously during the study; continuously was defined as >=5 days per week).
AstraZeneca did not provide details about either letter, although it indicated that the FDA requested additional information. The company said it would continue discussions with the regulatory agency to determine paths forwards for both applications.
The FDA in April approved Vimovo (naproxen/esomeprazole magnesium), a fixed-dose combination agent AstraZeneca developed in conjunction with Pozen Inc. that incorporates delayed-release, enteric-coated naproxen and an immediate-release version of esomeprazole. The product is a delayed-release tablet for relieving the signs and symptoms of osteoarthritis, rheumatoid arthritis, and ankylosing spondylitis and for decreasing the risk of developing gastric ulcers in patients who are at risk of developing them from using NSAIDs.
Nexium is already approved to reduce the risk of the occurrence of gastric ulcers associated with continuous NSAID therapy in patients who are at risk of developing gastric ulcers.
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