FDA gives approval for Gilead’s hepatitis C therapy
pharmafile | July 19, 2017 | News story | Research and Development, Sales and Marketing | FDA, Gilead, US, Vosevi, biotech, drugs, healthcare, pharma, pharmaceutical
The FDA has announced that it has chosen to approve Vosevi (sofosbuvir/velpatasvir/voxilaprevir), Gilead’s investigational drug for the treatment of chronic hepatitis C virus (HCV), a month after the organisation’s Committee for Medicines Products for Human Use (CHMP) recommended its use.
Specifically, the drug is approved for the indication of chronic HCV genotypes 1-6 without cirrhosis (liver disease) or with mild cirrhosis, meaning it is the first approved drug for patients previously treated with NS5a inhibitors such as sofosbuvir.
The decision was ultimately made based on data generated from clinical trials which showed that around 97% of patients using Vosevi had signs of HCV in their blood 12 weeks after finishing treatment.
“Direct-acting antiviral regimens have transformed HCV treatment and have allowed health care providers the fortunate opportunity to cure many patients,” explained Ira Jacobson, principal investigator in the trial and Chairman of the Department of Medicine at Mount Sinai Beth Israel, New York City. “However, for patients who require re-treatment, there remains an unmet clinical need for an effective and well-tolerated option. Treatment with Vosevi resulted in high cure rates in clinical studies of patients who were not previously cured with several widely-prescribed DAA regimens and will provide physicians with an important new therapeutic option that could offer hope for their hardest-to-treat patients.”
Chronic HCV affects up to an estimated 3.9 million people in the US alone and can lead to liver failure if untreated, eventually becoming fatal.
“The evolution of Gilead’s portfolio of HCV single-tablet regimens has been driven by our commitment to address previously unmet needs and put the possibility of cure within reach for as many HCV patient populations as possible,” Gilead’s President and Chief Executive Officer John F Milligan commented. “The approval of Vosevi completes our portfolio by fulfilling the unmet need for an effective regimen for patients who could not be cured, despite prior treatment with certain DAA regimens.”
Matt Fellows
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