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Gilead submits NDA to FDA for chronic hepatitis treatment, launches early access program.

Gilead Sciences, Inc., Foster City, CA announced it has submitted a New Drug Application (NDA) to the US Food and Drug Administration (FDA) for marketing approval of adefovir dipivoxil 10 mg. The company says it is seeking an indication for the treatment of patients with chronic hepatitis B, including treatment-naive and treatment-experienced patients.

The application is supported by data from Phase III studies in hepatitis B "e" antigen-positive patients and chronic hepatitis B patients with lamivudine-resistent HBV, the company reports. Based on the unmet medical needs of patients with chronic hepatitis B, Gilead says it has submitted a request for a priority, or 6-month, review of the adefovir dipivoxil NDA. The company adds it will submit an application for marketing approval of the drug in Europe soon.

Earlier in the month, Gilead announced the initiation of an early access program in the US to provide adefovir dipivoxil to chronic hepatitis B patients with lamivudine-resistant HBV. A similar program opened in France in July 2002 and has enrolled 289 patients to date. Additional programs in Canada, Australia and other countries in Europe will open in the coming months as regulatory approvals are obtained, the company says.

Contact: Amy Flood - (650) 522-5643, Web site: www.gilead.com
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Title Annotation:Gilead Sciences Inc. new drug application submitted to Food and Drug Adminstration
Comment:Gilead submits NDA to FDA for chronic hepatitis treatment, launches early access program.(Gilead Sciences Inc. new drug application submitted to Food and Drug Adminstration)
Publication:Transplant News
Article Type:Brief Article
Geographic Code:1USA
Date:Mar 31, 2002
Words:205
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