Gilead awaits EU decision on hep C combo treatment
pharmafile | December 8, 2015 | News story | Research and Development |Â Â EMA, Gilead, SOF/VEL, accelerated assessment, hepatitis C, sovaldi, velpatasvirÂ
The EMA has granted Gilead Sciences an accelerated assessment for its application for a new Sovaldi combination treatment.
The combination contains Sovaldi (sofosbuvir) and velpatasvir (SOF/VEL) for the treatment of hepatitis C.Velpatasvir is an investigational pan-genotypic NS5A inhibitor, for the treatment of chronic hepatitis C virus (HCV) infection.
Gilead is seeking aproval for the indication of SOF/VEL among patients with genotype 1-6 HCV infection, including patients with compensated and decompensated cirrhosis.
The application is supported by four Phase III ASTRAL trials, which evaluated the fixed-dose combination in hepatitis C genotypes 1-6. Of the 1,035 patients treated with SOF/VEL for 12 weeks in the ASTRAL-1, ASTRAL-2 and ASTRAL-3 studies, 1,015 – or 98% – of people achieved the primary efficacy endpoint of SVR12. This is when hepatitis C is undetectable for 12 or more weeks after the end of treatment.
The ASTRAL-4 study randomised 267 patients with decompensated cirrhosis to receive 12 weeks of SOF/VEL with or without RBV, or 24 weeks of SOF/VEL. Of the patients who received SOF/VEL plus RBV for 12 weeks, 94% achieved an SVR12, while 83% and 86% of patients who received SOF/VEL for 12 weeks and 24 weeks, respectively, achieved SVR12.
SOF/VEL is the third investigational medicinal product from Gilead for HCV infection to receive accelerated assessment by the EMA.
Gilead submitted SOF/VEL to the US FDA for approval in late October. The regulator granted the treatment Breakthrough Therapy designation.
Joel Levy
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