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Eisai's acid reflux drug gets US priority review

Sun Mar 2, 2008 5:26am EST
 
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TOKYO, March 2 (Reuters) - U.S. regulators have granted priority review for a new application of Eisai Co Ltd's (4523.T: Quote, Profile, Research, Stock Buzz) Aciphex acid reflux drug, Japan's fourth-largest drug maker said.

A priority review means the Food and Drug Administration (FDA) will likely decide within six months whether to approve the treatment, rather than the usual 10-month review period.

Aciphex, known chemically as rabeprazole sodium, belongs to a class of drugs known as proton pump inhibitors designed to suppress production of stomach acid that can burn and damage the esophagus, a condition known as gastroesophageal reflux disease.

Eisai said on Saturday that the FDA had accepted a supplemental New Drug Application (NDA) for Aciphex for the short-term treatment of gastroesophageal reflux disease in patients of age 12-16.

It said the FDA has indicated it would grant the new application priority review status.

Eisai derives nearly half of its U.S. drug sales from Aciphex and it is its second-biggest selling drug after Aricept, which is used to treat Alzheimer's disease.

It competes with other popular medicines such as Nexium and Prilosec from AstraZeneca (AZN.L: Quote, Profile, Research, Stock Buzz), Wyeth's (WYE.N: Quote, Profile, Research, Stock Buzz) Protonix and Prevacid from TAP Pharmaceuticals, a joint venture of Abbott Laboratories (ABT.N: Quote, Profile, Research, Stock Buzz) and Takeda Pharmaceutical Co (4502.T: Quote, Profile, Research, Stock Buzz).

A unit of Johnson & Johnson (JNJ.N: Quote, Profile, Research, Stock Buzz) (JNJ.N: Quote, Profile, Research, Stock Buzz) co-markets Aciphex with Eisai in the United States. (Reporting by Nathan Layne; Editing by Erica Billingham)

 

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