Janssen submits supplemental NDA for hepatitis C drug

Janssen Therapeutics, a subsidiary of US health care giant Johnson & Johnson (NYSE: JNJ), has submitted a supplemental New Drug Application (sNDA) to the US Food and Drug Administration to update the label for once-daily, all-oral Olysio (simeprevir) for hepatitis C.

The drug is currently 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 US biotech giant Gilead Sciences (Nasdaq: GILD).

Richard Nettles, vice president, medical affairs, Janssen Therapeutics, 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 III OPTIMIST trials, which adds to the body of clinical information about this combination in patients with and without cirrhosis.”