By RTT News,
June 16, 2014, 01:39:00 AM EDT
(RTTNews.com) - Biopharmaceutical company Gilead Sciences, Inc. ( GILD ) late Sunday announced that a Phase 3 clinical trial (GS-US-337-0113) in Japan evaluating the fixed-dose combination of Ledipasvir/Sofosbuvir met its primary endpoint of superiority.
The study was evaluating the investigational once-daily fixed-dose combination of the NS5A inhibitor ledipasvir 90 mg and the nucleotide analog polymerase inhibitor sofosbuvir 400 mg, with and without ribavirin, for the treatment of genotype 1 chronic hepatitis C virus or HCV infection.
The study met its primary endpoint of superiority compared to a predefined historical SVR12 rate. Patients who achieve SVR12 are considered cured of HCV infection.
The company noted that Genotype 1 is the most common strain of HCV in Japan, accounting for approximately 70 percent of the more than one million people chronically infected with the disease.
Based on these data, Gilead now plans to submit a New Drug Application for the LDV/SOF fixed-dose combination with the Japanese Pharmaceutical and Medical Devices Agency or PMDA by the end of 2014. The product is currently under regulatory review in the United States and European Union.
Gilead further said it plans to file for approval of sofosbuvir with the PMDA by mid-2014. Sofosbuvir as a single agent has been approved by regulatory authorities in the United States, European Union and Canada under the tradename Sovaldi.
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