AstraZeneca’s Esomeprazole PDUFA Date Set For March (NYSE:AZN)
A drug containing low aspirin and esomeprazole magnesium has been developed by AstraZeneca (NYSE:AZN), a major pharmaceutical company in the United States, over the last few years. Now the company is planning to bring thris drug into the market. For this purpose, a new drug application (NDA) was submitted to the Food and Drug Administration (FDA) on May 4, 2009. It usually takes the FDA 10 months to review a submitted NDA. So, the Prescription Drug User Fee Act (PDUFA) date of this drug – that is, the date on which the FDA will inform the company about whether it has accepted the NDA or not – is expected to be in March.
Meanwhile, the company also sent a variation of the NDA – called the supplemental new drug application (sNDA) to the FDA. This sNDA was submiited to get the regulator’s approval for marketing Nexium® (the brand name for the generic drug esomeprazole magnesium). This drug, as well as the drug containing asipriin/esomeprazole combination, aims to reduce the risks (especially those of duodenal and gastric cancer) associated with using low dose aspirin. The risks are even higher for patients who are being exposed to NSAID (non steroidal anti inflammatory drug) therapy.
Although aspirin can prevent heart diseases, heart attack and brain stroke, it can also cause peptic and stomach ulcers as well as less serious symptoms like stomach pain. Even low-dose aspirin is not safe. Many patients have stopped their NSAID therapy after facing such symptoms. In fact, one out of every three patients is likely to suffer from these symptoms and to discontinue their therapy.
To test the effectiveness as well as the safety of Nexium, the company carried out two trials. One of the trials was carried out on 40 mg and 20 mg of the drug, while the other was carried out on 20 mg of the drug. The 40/20 mg is used to treat erosive esophagitis (EE) for a period of 4 to 8 weeks while the 20 mg Nexium is used to treat EE for a longer period (usually greater than 6 months). Both these trials evaluated Nexium with placebo. The study results are included in the submitted sNDA and NDA
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