FDA
28th October 2013

FDA Panel Unanimously Supports Sofosbuvir for Hepatitis C

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.

FDA Panel Unanimously Supports Sofosbuvir for Hepatitis C

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:

  • P7977-1231 (FISSION) evaluated sofosbuvir + ribavirin (SOF + RBV) treatment for 12 weeks in treatment-naïve patients (499 patients: 256 in the SOF + RBV group; 243 in a pegylated interferon + ribavirin [PEG + RBV] group);
  • GS-US-334-0107 (POSITRON) evaluated SOF + RBV for 12 weeks in patients who were interferon intolerant, ineligible, or unwilling to take interferon (278 patients: 207 in the SOF + RBV group; 71 in the placebo group);
  • GS-US-334-0108 (FUSION) evaluated SOF + RBV for 12 or 16 weeks in treatment-experienced patients (201 patients: 103 in the SOF + RBV 12-week group; 98 in the SOF + RBV 16-week group).

In patients with HCV GT 1, 4, 5, or 6:

  • GS-US-334-0110 (NEUTRINO), evaluated SOF (400 mg once daily) + PEG (180 μg/week) + RBV (1000 or 1200 mg/day) for 12 weeks in treatment-naïve patients (N = 327).

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.

 

ISS has over a decade of experience in developing regulatory strategies including support for FDA Advisory Committee meetings. We are involved in more FDA AdComms per year than even the largest pharmaceutical companies. For more information on how ISS can help you prepare for your next meeting, contact info@innovativescience.net.

Do you want a more detailed analysis of this drug’s FDA AdComm meeting? Great news – ISS can help you! Click on the link below in order to receive a detailed post-meeting outcome report! 

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