Gilead seeks FDA approval of hepatitis B drug

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Gilead seeks FDA approval of hepatitis B drug  





Thursday March 21, 7:52 PM EST



FOSTER CITY, Calif., March 21 (Reuters) - Biotechnology company Gilead Sciences Inc. (GILD) said on Thursday it has asked the the U.S. Food and Drug Administration to approve its experimental hepatitis B treatment adefovir dipivoxil.



Gilead, based in Foster City, California, wants to sell the drug as a both an initial and a secondary treatment for patients with chronic hepatitis B, a viral infection that can cause liver disease.



Gilead also said it has asked the FDA for a priority, or six-month, review of the drug and plans to submit an application to European regulators shortly.



Adefovir dipivoxil belongs to a class of drugs called nucleotide analogues which are designed to work by blocking an enzyme involved in the replication of the hepatitis virus in the body.



The company said there are about 350 million chronic carriers of hepatitis B worldwide and about one million die each year from complications of the disease, which include cirrhosis (scarring of the liver), liver failure and liver cancer.





?002 Reuters Limited.