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news.Janssen Therapeutics has submitted a supplemental new drug application (sNDA) to the US Food and Drug Administration (FDA) to update the label for once-daily, all-oral Olysio (simeprevir), a hepatitis C virus (HCV) NS3/4A protease inhibitor.
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Currently, Olysio is approved for use with sofosbuvir for adults with genotype 1 chronic hepatitis C (CHC) infection as a 12-week treatment for patients without cirrhosis or a 24-week treatment regimen for patients with cirrhosis.
Sofosbuvir is a nucleotide analog NS5B polymerase inhibitor marketed by a US-based biotechnology firm Gilead Sciences.
Last November, Olysio was approved in combination with sofosbuvir based on the Phase II COSMOS clinical trial.
The sNDA is based on results from the Phase III OPTIMIST-1 and OPTIMIST-2 trials, which evaluated 12 and eight weeks of therapy for treatment-naive and treatment-experienced genotype 1 CHC adult patients without cirrhosis, and 12 weeks of therapy for treatment-naive and treatment-experienced genotype 1 CHC adult patients with cirrhosis.
Janssen Therapeutics Medical Affairs vice-president Richard Nettles said: "Olysio has contributed significantly to the care of people living with hepatitis C.
"The availability of multiple treatment options is important to help offer an opportunity for cure, and we believe Olysio will continue to play a meaningful role going forward.
"We’re pleased to submit the data from the Phase 3 OPTIMIST trials, which adds to the body of clinical information about this combination in patients with and without cirrhosis."
The randomized, open-label Phase III OPTIMIST-1 trial will investigate the efficacy and safety of the all-oral regimen of simeprevir and sofosbuvir (SMV/SOF) among treatment-naive and treatment-experienced genotype 1 CHC patients without cirrhosis.
OPTIMIST-2 is an open-label, single-arm Phase III trial, which will examine the efficacy and safety of SMV/SOF in treatment-naive and treatment-experienced genotype 1 CHC patients with cirrhosis.