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发表于 2002-4-2 16:52
Gilead sees a healthy future for hepatitis drug
Brendan Doherty
Foster City-based Gilead Sciences filed its anticipated new drug application with the U.S. Food and Drug Administration March 22 for Adefovir, a drug for hepatitis B.
The company filed for an expedited review which, if accepted, could cut the FDA's normal one-year review time in half.
The main advantage of Adefovir over GlaxoSmithKline's Epivir may be that the drug does not allow the disease to mutate in the patients, making the already-chronic disease even more drug-resistant.
"From the data, we have not seen any development of resistance mutation," said Susan Hubbard, spokesman for Gilead.
Adefovir showed effectiveness against the disease when pitted against a placebo in a 48-week trial. In conjunction with the filing, Gilead has released Adefovir free of charge, in an early access program, to anyone with hepatitis B.
The drug's progress and the filing is the latest in a string of good news for Gilead. The company and its partner, Hoffman-La Roche, received positive recommendations for their oral antiviral flu medication Tamiflu in Europe. Gilead also saw positive data from a study designed to test if Viread, an antiviral drug approved for HIV in October of 2001, would have an effect on hepatitis B as well. It appears that it does.
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