The European Medicines Agency (EMA) has validated Gilead Sciences’ marketing authorisation application (MAA) for investigational Chronic Hepatitis C Therapy Sofosbuvir / Velpatasvir / Voxilaprevir (SOF / VEL / VOX).
The once-daily, single tablet regimen of sofosbuvir 400mg, velpatasvir 100mg and voxilaprevir 100mg (SOF / VEL / VOX) will be used to treat chronic hepatitis C virus (HCV)-infected patients.
The agency is currently assessing the application.
Gilead Sciences executive vice-president of research and development and chief scientific officer Norbert Bischofberger said: “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.
“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.”
The MAA is supported by data from POLARIS-1 and POLARIS-4 Phase III studies, as part of which 12 weeks of the fixed-dose combination was evaluated in direct-acting antiviral (DAA)-experienced patients with hepatitis C genotypes 1-6.
Those who failed prior treatment with an NS5A inhibitor-containing regimen were also evaluated as part of the studies.
The primary efficacy endpoint of SVR12 was achieved by 97% of patients treated with SOF / VEL / VOX across the studies.
The MAA also includes data from POLARIS-2 and POLARIS-3 additional phase III studies, which evaluated eight weeks of SOF / VEL / VOX in 611 DAA-naïve patients with genotypes 1-6.
In POLARIS-3, 96% of patients with genotype 3 infection and cirrhosis treated with SOF / VEL / VOX achieved the primary efficacy endpoint.
Patients who received SOF / VEL / VOX were found to have the most common adverse events such as headache, fatigue, diarrhoea and nausea.
The EMA will review SOF / VEL / VOX under the centralised licencing procedure for all 28 member states of the European Union, Norway and Iceland.
Image: Hepatitis C virus (HCV). Photo: courtesy of BruceBlaus.