Gilead Submits NDA For Hepatitis C Fixed Dose Treatment
Gilead Sciences announced it has filed a New Drug Application for its genotype 1 hepatitis C infection treatment Ledipasvir/Sofosbuvir fixed-dose combination. If the U.S. FDA grants approval, the fixed dose combination would eliminate the need for existing treatments Interferon and Ribavirin.
NS5A inhibitor Ledipasvir 90 mg and nucleotide analog polymerase inhibitor Sofosbuvir 400 mg fixed-dose combination would be the first oral treatment regimen for patients with genotype 1 HCV infection if it wins approval from the FDA. Three Phase III studies (ION-1, ION-2 and ION-3,) supported the NDA for LDV/SOF. Almost 2,000 genotype 1 HCV patients were randomized to receive LDV/SOF therapy with or without RBV for eight, 12, or 24 week treatment durations. Supporting data in the NDA recommends the use of LDV/SOF in treatment duration of eight or 12 weeks depending on patients’ prior treatment history and whether they are cirrhosis positive.
Hepatitis C is a contagious liver disease caused by the hepatitis C virus. Approximately 150 million people are chronically infected with the virus, with over 350,000 hepatitis-C related deaths every year. 75% of patients infected with HCV in the U.S. are estimated to have the genotype 1 strain of the virus.
Gilead Executive Vice President of Research and Development and Chief Scientific Officer Norbert Bischofberger, PhD, said, “Today’s filing brings us one step closer to our goal of offering all patients with hepatitis C a simple, safe and highly effective all-oral treatment regimen. Based on the data from the Phase 3 ION studies, the LDV/SOF combination may have the potential to cure HCV in genotype 1 patients in as little as eight weeks and without the need for interferon injections or ribavirin.”
The FDA has currently assigned Breakthrough Therapy designation for LDV/SOF. The company said it also has plans to file for regulatory approval of the LDV/SOF combination therapy in the European Union in the first quarter of 2014.