EMA validates Gilead’s marketing application for their Hep C therapy
Posted: 23 January 2017 | | No comments yet
The application is supported by data from two Phase 3 studies, which evaluated 12 weeks of the fixed-dose combination in antiviral-experienced patients…
Gilead Sciences’ marketing authorisation application for the investigational regimen of sofosbuvir 400 mg, velpatasvir 100 mg, and voxilaprevir 100 mg (sof/vel/vox) for the treatment of chronic hepatitis C virus -infected patients has been fully validated. It is now under assessment by the European Medicines Agency (EMA).
“Direct-acting antiviral treatments have transformed our ability to treat hepatitis C; however, for some patients who have failed to achieve a cure with these regimens, effective and well-tolerated therapies are still needed,” said Norbert Bischofberger, PhD, Executive VP of Research and Development and CSO at Gilead.
“The submission of this application reflects our continued commitment to provide treatment options for this life-threatening disease to as many patients as possible, including those who have failed previous direct-acting antiviral therapy, in Europe and around the world.”
Supporting studies
The application is supported by data from two Phase 3 studies, which evaluated 12 weeks of the fixed-dose combination in direct-acting antiviral-experienced patients with hepatitis C genotypes 1-6, including those who failed prior treatment with an NS5A inhibitor-containing regimen.
Across the two studies, 97% of patients treated with the therapies achieved the primary efficacy endpoint of sustained viral response at 12 weeks.
Additional studies
The MAA also includes data from two additional phase 3 studies, which evaluated 8 weeks of treatment in 611 DAA-naïve patients with genotypes 1-6.
In one of the additional studies, 96% of patients with genotype 3 infection and cirrhosis treated with sof/vel/vox achieved the primary efficacy endpoint of sustained viral response at 12 weeks.
The most common adverse events among patients who received sof/vel/vox were headache, fatigue, diarrhoea and nausea.
Sof/vel/vox will be reviewed by the EMA under the centralised licensing procedure for all 28 member states of the European Union, Norway and Iceland.
The review will follow an accelerated procedure reserved for medicinal products expected to be of major public health interest. Gilead also submitted a new drug application to the US FDA in December last year.
Sof/vel/vox is an investigational product and its safety and efficacy has not been established.
