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Janssen submits NDA for simeprevir/sofosbuvir combination HCV regimen
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Janssen submitted a supplemental new drug application to the FDA for a once-daily, all-oral regimen of simeprevir in combination with sofosbuvir for the treatment of chronic hepatitis C genotype 1 infection in treatment-naive adult patients, according to a news release from the drug maker.
“Hepatitis C places a significant burden on the lives of those infected and if left untreated may cause significant damage to the liver, including cirrhosis and complications such as liver failure,” Gaston Picchio, PhD, hepatitis disease area leader for Janssen Research and Development, said in the release. “This filing brings us closer to potentially offering these patients a once-daily all-oral treatment combination that includes the direct-acting antiviral agents simeprevir and sofosbuvir.”
Janssen’s application is based on results from the phase 2 COSMOS trial, which investigated the efficacy of a daily fixed-dose of simeprevir and sofosbuvir, with or without ribavirin, for 12 or 24 weeks. The regimen led to high rates of sustained virologic response in patients with HCV, including null-responders with different stages of advanced liver fibrosis and treatment-naive patients with advanced fibrosis.
Earlier this year, Janssen announced it was initiating the phase 3 OPTIMIST trials, which will assess the safety and efficacy of the combination treatment without interferon or ribavirin for HCV genotype-1 infection. For the first trial, investigators again will combine simeprevir and sofosbuvir and administer the fixed-dose regimen for 8 or 12 weeks to HCV patients without cirrhosis who are either treatment-naive or experienced. For the second trial, OPTIMIST-2, the regimen will be administered for 12 weeks to cirrhotic patients with chronic HCV infection who are either treatment-naive or experienced.
Simeprevir (Olysio, Janssen) is an NS3/4A protease inhibitor that was approved by the FDA in November 2013. Sofosbuvir (Sovaldi, Gilead), a NS5B polymerase inhibitor, was approved in December 2013.