Gilead Sciences, Inc. (NASDAQ:GILD) has recently submitted to the US Food and Drug Administration (FDA) a New Drug Application (NDA) for an investigational candidate containing 400 mg of sofosbuvir, 100 mg of velpatasvir, and 100 mg of voxilaprevir (SOF/VEL/VOX) for the treatment of direct-acting antiviral (DAA)-experienced chronic hepatitis C virus (HCV) patients.
NDA Submission
The company has submitted along with its NDA supporting data from POLARIS-1 and POLARIS-4, two Phase 3 clinical trials evaluating SOF/VEL/VOX in a 12-week period among DAA-experienced patients with genotype 1 to 6 HCV infection with compensated cirrhosis or without cirrhosis. About 97% of the subjects have achieved the primary endpoint establishing the efficacy of the regimen.
The company believes that there is a growing need for a safe and effective treatment for HCV patients who have failed prior treatments with DAA regimens.
“SOF/VEL/VOX has the potential to fill that need by offering single tablet dosing and high cure rates across all HCV genotypes for patients with and without cirrhosis, who have failed prior treatment with other highly effective regimens,” reiterated Norbert Bischofberger, Ph.D., Gilead Sciences Chief Scientific Officer (CSO) and Executive Vice President (EVP) of Research and Development (R&D).
Gilead Sciences has also submitted the results from POLARIS-2 and POLARIS-3, two additional Phase 3 clinical trials evaluating SOF/VEL/VOX in an eight-week period among DAA-naïve HCV patients.
These data have first been presented last month at the Annual Meeting of the American Association for the Study of Liver Diseases (AASLD).
James Meyers’ Promotion
In other news, Gilead Sciences has confirmed last month the promotion of Meyers, former Gilead Sciences Senior VP (SVP) of North American Commercial Operations, as the new EVP of Worldwide Commercial Operations. Consequently, Meyers now spearheads the company’s commercial operations in Europe, Japan, and North America.
Meyers has joined Gilead Sciences in 1996. For 20 years now, he has always been a major player in shaping up the company’s commercial operations in North America.
Kevin Young, Gilead Sciences Chief Operating Officer (COO), is confident that with more responsibilities as an executive leader, Meyers will become more valuable to the company.
On Friday, Gilead Sciences has closed at $72.70.