Gilead Sciences, Inc. (Nasdaq: GILD) announced that the U.S. Food and Drug Administration’s (FDA) Antiviral Drugs Advisory Committee unanimously voted in support of approval of the company’s investigational antiviral agent, adefovir dipivoxil 10 mg, for the treatment of chronic hepatitis B.
The committee’s positive recommendation followed today’s presentation by Gilead and the FDA of efficacy and safety data from clinical studies of adefovir dipivoxil in a broad range of patients with chronic hepatitis B. The FDA will consider the Advisory Committee’s recommendations as it completes its priority review of the adefovir dipivoxil New Drug Application (NDA), submitted on March 21, 2002.
If approved, adefovir dipivoxil will be the first commercially available nucleotide for use in the treatment of chronic hepatitis B and the first new treatment approved for the disease since 1998. Advisory committee members unanimously agreed that the adefovir dipivoxil pivotal study data supports the drug’s safety and efficacy in patients with chronic hepatitis B. Several Committee members suggested that monitoring for changes in laboratory markers of renal function in patients with impaired renal function should be included in the adefovir dipivoxil product label.
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