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news.Gilead Sciences has submitted a new drug application (NDA) to Japan’s Pharmaceutical and Medical Devices Agency (PMDA) seeking approval for an investigational once-daily fixed-dose combination (FDC) of the NS5A inhibitor ledipasvir (LDV) 90mg and the nucleotide analog polymerase inhibitor sofosbuvir (SOF) 400mg to treat chronic genotype 1 hepatitis C virus (HCV) infection in adults.
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The data submitted in the NDA includes a Japanese Phase III trial, which showed 100% SVR12 rates and patients who achieve SVR12 are cured of HCV infection.
The NDA supports the use of LDV/SOF for 12 weeks in treatment-naïve and treatment-experienced patients with chronic genotype 1 HCV infection, including those with cirrhosis.
If approved, the FDC of LDV/SOF will reduce the need for interferon and ribavirin (RBV) and will simplify HCV treatment for genotype 1 patients in the country to one daily tablet.
Around 341 treatment-naïve and treatment-experienced genotype 1 patients were included in the Phase III trial and adverse events observed with LDV/SOF without RBV were generally mild and included nasopharyngitis, headache and malaise.
Currently, the FDC of LDV/SOF is under regulatory review in the US and European Union.
The NDA is also supported by SVR12 results from three Phase III trials (ION-1, ION-2 and ION-3) evaluating eight, 12 or 24 weeks of LDV/SOF among genotype 1 HCV patients from the US, Europe and Puerto Rico.