Gilead's new drug application for a once-daily, fixed dose combination of ledipasvir/sofosbuvir for the treatment of chronic hepatitis C genotype 1 infection in adults has been given priority review by the FDA.
Gilead Sciences announced today that the FDA has granted priority review to the company’s new drug application for a once-daily, fixed-dose combination of the NS5A inhibitor ledipasvir 90 mg and the nucleotide analog polymerase inhibitor sofosbuvir 400 mg for the treatment of chronic hepatitis C genotype 1 infection in adults.
According to Gilead, the data submitted in the NDA “are from three Phase 3 studies, ION-1, ION-2 and ION-3, and support the use of LDV/SOF in adults with genotype 1 HCV infection, with a treatment duration of eight or 12 weeks depending on prior treatment history and whether they have cirrhosis.”
The FDA has also granted the drug a “breakthrough therapy” designation, reserved for experimental drugs that may offer large treatment advances over other, already existing options.
The FDA has announced October 10, 2014, as the target date for an approval decision.