Gilead Seeks New Indication In Japan For Sovaldi In Genotype 2 HCV

Gilead Sciences announced in a press release it has requested that the Pharmaceutical and Medical Devices Agency (PMDA) of Japan approve its New Drug Application (NDA) for Sovaldi (sofosbuvir). The nucleotide analog polymerase inhibitor treats chronic hepatitis C virus (HCV) infection. Gilead’s NDA is for sofosbuvir with ribavirin (RBV) in patients with genotype 2 HCV infection. The NDA is Gilead’s first in Japan and if approved, Sovaldi would be the first drug marketed by Gilead in Japan.

Norbert Bischofberger, Gilead's EVP of Research and Development and CSO, said, "Based on Phase 3 studies, we believe that sofosbuvir has the potential to provide high cure rates among genotype 2 patients in just 12 weeks of interferon-free therapy.”

Sovaldi

The NDA request occurs at a time when the industry is debating the high costs of drugs like Sovaldi, which is sold at a price of $1,000 a pill in the U.S. In Japan, where the government regulates drugs and prices, the NDA is likely to be considered in an environment of cost consciousness. Recently the Scottish Medicines Consortium (SMC) decided that the Sovaldi price was too high and restricted it to patients only if conventional treatments failed. In the U.K., the National Institute for Health and Care Excellence (NICE) has requested more information on the cost-effectiveness of Sovaldi before authorizing and funding the drug.

Gilead’s application seeking a new indication in Japan was based on a Phase III clinical trial. The study, conducted in Japan, evaluated treatment-naïve and treatment-experienced genotype 2 patients. Investigators found that 97 percent of patients achieved a sustained virologic response 12 weeks after completing therapy. Physicians consider those patients cured.

Sovaldi and Ledipasvir

Gilead is also conducting trials of sofosbuvir and ledipasvir in a Phase III trial in Japan treating genotype 1 HCV infected patients, the most common strain of HCV in Japan. Participants are taking a once-daily fixed-dose combination of sofosbuvir (400 mg) and the NS5A inhibitor ledipasvir (90 mg), with and without RBV. Gilead intends to file an NDA in Japan for this indication in the second half of 2014.