Gilead gains EU approval for Hep Combination Treatment – Vosevi
Gilead Sciences obtained a big achievement with its Hepatitis C treatment Vosevi (drug which comprises of Sofosbuvir/Velpatasvir/Voxilaprevir) becoming the first and only single tablet regimen for patients who have previously failed therapy with direct-acting antivirals (DAA).
The drug was approved to treat adults with genotype 1-6 chronic hepatitis virus (HCV) infection as a 12-week regimen for patients without cirrhosis or with compensated cirrhosis.
Supported by data from two Phase III studies, POLARIS-1 and POLARIS-4 evaluated 12 weeks of the single tablet regimen in patients with hepatitis C genotypes 1-6 who were previously treated unsuccessfully with DAA-containing regimens, including NS5A inhibitors.
Results show that 97% of patients on Vosevi had achieved the primary efficacy endpoint of a sustained viral response (SVR) for 12 or more weeks post-treatment.
John Milligan, President and Chief Executive Officer, Gilead, said: “The authorisation of Vosevi demonstrates our ongoing commitment to bring therapies with high cure rates to all HCV-infected patients.”
The European Commission also approved an extension for Harvoni (Ledipasvir/Sofobuvir), which was previously approved to treat adults with chronic HCV genotypes 1, 3, 4, 5, or 6, and will now include the treatment in adolescents aged 12 to 18 years.
This marks another win for the biopharma as Harvoni is the first DAA chronic HCV treatment to be granted an extension to treat adolescents in the European Union.
Milligan added: “We look forward to working with healthcare providers and government to ensure Vosevi is made available to patients who would benefit the most from it, while continuing to expand the benefits of our other approved medicines for patients with chronic HCV infection across Europe.”
Vosevi has already had the US FDA go-ahead back in July for the re-treatment of adults with genotype 1-6 chronic HCV infection.