On Friday, the FDA’s Antiviral Drugs Advisory Committee unanimously voted (15-0) to recommended approval of Gilead Sciences Inc’s experimental hepatitis C drug.
On Friday, the FDA’s Antiviral Drugs Advisory Committee unanimously voted (15-0) to recommended approval of Gilead Sciences Inc’s experimental hepatitis C drug, sofosbuvir (SOF) in combination with ribavirin for the treatment of adults with chronic hepatitis C virus (HCV) genotypes (GT) 2 and 3 infections.
The committee also recommended (15-0) sofosbuvir in combination with pegylated interferon and ribavirin for treatment of chronic HCV in treatment-naïve adults with GT 1 and 4 infections who have not received prior therapy. Genotype 1 accounts for roughly 70 percent of hepatitis C cases.
The vote follows a discussion of 4 pivotal phase 3 clinical trials which all showed that sofosbuvir-based regimens achieved the primary endpoint of sustained virologic responses (SVRs) in as little as 12 weeks, and were either superior or non-inferior to currently-available treatments that take as long as 48 weeks for therapy:
In patients with HCV GT 2 or 3:
In patients with HCV GT 1, 4, 5, or 6:
Sofosbuvir is an NS5B polymerase inhibitor and the first drug in this class to be reviewed in the US. It is intended to be administered as a 400-mg oral dose once daily in combination with other drugs. The approval is significant because it provides the first interferon-free regimen for adult patients with HCV GTs 2 and 3.
“This is a tremendous advance for patients, and I think both the sponsor and the FDA should be applauded for having gotten us here,” said voting member Elizabeth Connick, MD, a professor of medicine at University of Colorado Denver, Division of Infectious Diseases, in Aurora, Colorado.
In addition to the US application, Gilead has filed for approval of sofosbuvir in the EU, Switzerland, Canada and Australia/New Zealand.
Today in the EU, the drug received a recommendation today under the European Medicines Agency’s compassionate use programme, which is intended to give patients with a life-threatening, long-lasting or seriously disabling disease who have no available treatment options or access to treatments that are still under development.
About 4 million Americans have hepatitis C, according to the US National Institutes of Health (NIH). Gilead’s president, John Milligan recently stated that around 1 million patients have been diagnosed and around 350,000 are receiving some form of treatment. If approved, sofosbuvir may become a major new treatment for hepatitis C. The agency is due to deliver its decision by December 8.
The FDA is not bound to follow the advice of its panels but typically does so.
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