US regulators have approved Gilead’s Epclusa (sofosbuvir/velpatasvir) to treat adult patients with chronic hepatitis C virus (HCV) both with and without cirrhosis.
The combination of Gilead’s blockbuster Sovaldi (sofosbuvir) and velpatasvir is the first all-all single tablet treatment for all six major forms of hepatitis C.
Edward Cox, director of the Office of Antimicrobial Products in the FDA’s Center for Drug Evaluation and Research, said: “This approval offers a management and treatment option for a wider scope of patients with chronic hepatitis C.”
The FDA approval was based in part on clinical trials showing that 95-99% of patients without cirrhosis or with mild cirrhosis who received Epclusa had no virus detected in the blood 12 weeks after finishing treatment, suggesting their infections had been cured.
The drug had been reviewed under the FDA’s priority review programme, which provides for an expedited review of drugs that treat serious conditions and, if approved, would provide significant improvement in safety or effectiveness.
John Milligan, president and CEO of Gilead, said: “[This] approval represents a significant advance for patients with HCV genotypes 2 and 3, who previously required more complex and costly regimens.
“As the first and only pan-genotypic cure for hepatitis C, Epclusa has the potential to eliminate the need for genotype testing, which can be a barrier to treatment in certain resource-constrained settings.”
The combination is also set for European approval in the coming months, following its CHMP recommendation alongside Merck & Co’s rival Zepatier (elbasvir/grazoprevir) in May.
Epclusa joins Sovaldi and Harvoni (sofosbuvir/ledipasvir), a product specifically indicated for patients with hepatitis C virus genotype 1 infection, in Gilead’s hep C portfolio.
Sovaldi and Harvoni brought in sales of $5.3bn and $13.9bn respectively last year, well ahead of new rivals such as AbbVie’s Viekira Pak (ombitasvir/paritaprevir/ritonavir and dasabuvir) which brought in $1.6bn in the same period.