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FDA grants priority review for ledipasvir/sofosbuvir
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The FDA has granted a priority review to a new drug application for a combination of ledipasvir and sofosbuvir to treat chronic hepatitis C virus infection genotype 1, according to a press release from Gilead Sciences.
Gilead said the application includes expedited review of a fixed once-daily tablet combination of its 90 mg ledipasvir (LDV), a NS5A inhibitor, and 400 mg sofosbuvir (SOF), a polymerase inhibitor, to treat hepatitis C virus (HCV) in adults for 8 or 12 weeks. The combination’s safety and efficacy have yet to be determined.
Gilead submitted data from three phase 3 studies, ION-1, ION-2 and ION-3; treatment will be based on patients’ prior treatment histories for HCV and whether they have cirrhosis, according to the release.
The FDA also has assigned LDV/SOF breakthrough therapy designation, which gives priority review status to medicines that may offer major treatment advances. A marketing application for LDV/SOF is under review by the European Commission and was validated by the European Medicines Agency in March 2014.
The FDA approved SOF (Sovaldi) in December 2013, and the European Commission gave its OK in January.