Janssen submits supplemental new drug application for Olysio

Janssen Therapeutics, announced they have submitted a supplemental new drug application to the FDA to update the label for Olysio, its protease inhibitor, currently approved for use in adults with hepatitis C virus genotype 1 infection, according to a press release.

Olysio (simeprevir, Janssen Therapeutics) is a NS3/4A protease inhibitor that functions by blocking the viral protease enzyme HCV uses to replicate. It was approved by the FDA in November 2013 as part of an antiviral treatment regimen with pegylated interferon and ribavirin for patients with chronic HCV genotype 1 and is currently approved for use in combination with Sovaldi (sofosbuvir, Gilead Sciences).

Sofosbuvir, a nucleotide analog NS5B polymerase inhibitor, was first approved by the FDA in December 2013 as an oral tablet, to serve as a component of a combination antiviral treatment regimen to treat chronic HCV.

In November 2014, simeprevir was approved to be combined with sofosbuvir based on clinical data from the phase 2 COSMOS clinical trial. This new supplemental application is based on results from the phase 3 OPTIMIST-1 and -2 trials, which evaluated 8 and 12 weeks of therapy for treatment-naive and treatment-experienced adults with HCV genotype 1 without cirrhosis, and 12 weeks of therapy for adult patients with chronic HCV genotype 1 and cirrhosis who were treatment-naive and treatment-experienced, according to the release.

“Olysio has contributed significantly to the care of people living with hepatitis C,” Richard Nettles, MD, vice president of medical affairs at Janssen Therapeutics, said in the release. “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.”

In the OPTIMIST-1 trial, 97% of patients treated with the combination regimen for 12 weeks achieved sustained virologic response at 12 weeks (n = 150/155), with minimal adverse events. In the OPTIMIST-2 trial, the SVR12 rates was 84% (n = 86/103).

In April, the FDA approved changes to the Olysio label, after reports of some patients taking the regimen experienced hepatic decompensation and failure, as well as serious symptomatic bradycardia.

Disclosure: Nettles reports being employed by Janssen Therapeutics.