AstraZeneca’s (AZN) gastrointestinal franchise received a setback recently with the US Food and Drug Administration (FDA) issuing complete response letters (CRL) for two applications submitted by the company.
The first CRL relates to AstraZeneca’s new drug application on Axanum, a single capsule of Nexium and aspirin. AstraZeneca had submitted the NDA in April 2009 and was seeking to get the drug approved for the risk reduction of low dose acetylsalicylic acid (ASA)-associated gastric and/or duodenal ulcers in patients at risk.
The NDA was based on results from the OBERON and ASTERIX studies, which were conducted to evaluate the safety and efficacy of Nexium in reducing the risk of gastric and/or duodenal ulcers in patients taking low-dose ASA continuously during the studies.
The second CRL related to a supplemental new drug application (sNDA) filed by AstraZeneca for Nexium. AstraZeneca was looking to get Nexium’s label expanded so that it can be used for the risk reduction of low-dose aspirin-associated peptic ulcers. The Nexium sNDA was also submitted in April 2009.
The delay in gaining approval for Axanum and the Nexium label expansion is a setback for AstraZeneca, which has been looking to drive sales of its gastrointestinal franchise, which came in at $6 billion in 2009.
Nexium is the lead product in the gastrointestinal franchise. However, Nexium sales, which came in at $4,959 million (down 1%), have been under pressure in the U.S., mainly due to increased competition from generic and over-the-counter drugs. New product approvals and label expansions would help increase product sales.
Given the lack of details regarding the CRLs, there is limited visibility regarding the future regulatory path for Axanum and the Nexium label expansion. AstraZeneca said that it intends to meet with the FDA and will also respond to the FDA’s request for additional information.
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