Gilead Sciences submitted a new drug application (NDA) to the FDA for a once-daily fixed-dose combination of 90 mg ledipasvir plus 400 mg sofosbuvir for treating chronic hepatitis C genotype 1 infections in adults.
Data from a trio of phase 3 ION studies, suggest the ledispasvir/sofosbuvir combination may elicit sustained virologic response in patients with HCV genotype 1 in as little as eight weeks and without the need for interferon injections or ribavirin [RBV].
The FDA previously awarded ledispasvir/sofosbuvir breakthrough therapy designation.
In the three studies, nearly 2,000 patients with genotype 1 HCV were randomly assigned to the fixed-dose combination, with or without RBV, for durations of eight, 12 or 24 weeks. Patients were treatment-naive or had failed on previous treatment, including protease inhibitor-based regimens.
Additionally, Gilead plans to file for regulatory approval of ledispasvir/sofosbuvir in other countries and submitted an application to the European Medicines Agency for accelerated assessment of ledispasvir/sofosbuvir. If accepted, the assessment could decrease the review time of the tablet by 2 months.