Gilead’s Harvoni Approved by European Regulators
European regulators have granted regulatory approval to Gilead Sciences’ hepatitis C combination treatment, Harvoni.
Harvoni combines Gilead’s Sovaldi (sofosbuvir), a nucleotide analogue polymerase inhibitor, with NS5A inhibitor, ledipasvir, for HCV genotype 1 and 4 infection.
The approval from the European Commission comes a month after the US FDA granted approval for the drug. The approval is significant as Harvoni offers a once-daily, all-oral interferon- and ribavirin-free treatment option for HCV.
The approval by the regulatory body is founded on three Phase III clinical studies which showed that Harvoni achieved cure rates – sustained virologic response – (SVR 12) of 94%-99%.
Graham Foster of the Queen Mary University, London commented that both genotype 1 patients “and the physicians who treat them have been waiting for a treatment advance like this for decades.”
Foster added that “with Harvoni, we have the potential to change the way we treat people living with the most prevalent form of HCV in Europe.”