The FDA has declined to approve AstraZeneca's (NYSE: AZN) Axanum, a combination of aspirin and esomeprazole, the main ingredient in the blockbuster drug Nexium. The drug is an experimental treatment for the prevention of ulcers. Additionally, the FDA issued a complete response letter for Nexium for reducing the risk of low-dose aspirin-associated peptic ulcers.
It's a setback for AstraZeneca, which is attempting to extend Nexium's usage before the $5 billion-a-year drug goes off patent in 2014. But the drugmaker has had some success developing line-extension products: It recently received approval of Vimovo, which was developed with Pozen. Vimovo contains naproxen and esomeprazole, and treats arthritis patients in danger of developing an ulcer. In a statement, AstraZeneca says it's evaluating the CRLs and will continue discussions with the FDA to determine next steps with respect to both the Axanum NDA as well as the Nexium sNDA.