FDA approvals

Simeprevir combination therapy approved as hepatitis C treatment

The FDA has approved simeprevir as part of an antiviral treatment regimen with pegylated interferon and ribavirin for the treatment of patients with chronic hepatitis C genotype 1.

The therapy is intended for treatment-naïve and treatment-experienced patients with compensated liver disease, including cirrhosis.

“Olysio [simeprevir, Janssen Therapeutics] is the third FDA-approved protease inhibitor to treat chronic hepatitis C virus infection, and provides health professionals and patients with a new, effective treatment for this serious disease,” Edward Cox, MD, director of the Office of Antimicrobial Products in the FDA’s Center for Drug Evaluation and Research, said in an FDA statement.

Ed Cox, MD 

Edward Cox

The FDA approved Victrelis (boceprevir, Merck) and Incivek (telaprevir, Vertex Pharmaceuticals) for the treatment of hepatitis C in 2011.

Simeprevir is a NS3/4A protease inhibitor that functions by blocking the viral protease enzyme the hepatitis C virus uses to replicate. Its approval follows 5 clinical studies involving 2,026 patients that demonstrated its safety and effectiveness.

The randomized studies found 80% of treatment-naïve patients taking the now-approved therapy demonstrated sustained virologic response at week 12, compared with 50% of the patients given placebo plus peginterferon-alfa and ribavirin. The addition of simeprevir also increased SVR12 rates compared with a placebo treatment among prior relapsers, partial responders and null responders.

The therapy is substantially less successful in treating prior-relapser patients with the Q80K polymorphism, according to a press release from Johnson & Johnson. Janssen is a subsidiary of Johnson & Johnson.

In one study, 30% of patients with Q80K polymorphism in the placebo arm achieved SVR12, compared with 47% of the patients with Q80K in the therapy arm. Among patients without the polymorphism in the treatment arm, 78% achieved SVR12, the release said.

Jannsen maintains exclusive worldwide marketing rights to Olysio, except in the Nordic countries, where Medivir maintains these rights. A marketing authorization agreement for Olysio was submitted to the European Medicines Agency in April 2013.

The FDA has approved simeprevir as part of an antiviral treatment regimen with pegylated interferon and ribavirin for the treatment of patients with chronic hepatitis C genotype 1.

The therapy is intended for treatment-naïve and treatment-experienced patients with compensated liver disease, including cirrhosis.

“Olysio [simeprevir, Janssen Therapeutics] is the third FDA-approved protease inhibitor to treat chronic hepatitis C virus infection, and provides health professionals and patients with a new, effective treatment for this serious disease,” Edward Cox, MD, director of the Office of Antimicrobial Products in the FDA’s Center for Drug Evaluation and Research, said in an FDA statement.

Ed Cox, MD 

Edward Cox

The FDA approved Victrelis (boceprevir, Merck) and Incivek (telaprevir, Vertex Pharmaceuticals) for the treatment of hepatitis C in 2011.

Simeprevir is a NS3/4A protease inhibitor that functions by blocking the viral protease enzyme the hepatitis C virus uses to replicate. Its approval follows 5 clinical studies involving 2,026 patients that demonstrated its safety and effectiveness.

The randomized studies found 80% of treatment-naïve patients taking the now-approved therapy demonstrated sustained virologic response at week 12, compared with 50% of the patients given placebo plus peginterferon-alfa and ribavirin. The addition of simeprevir also increased SVR12 rates compared with a placebo treatment among prior relapsers, partial responders and null responders.

The therapy is substantially less successful in treating prior-relapser patients with the Q80K polymorphism, according to a press release from Johnson & Johnson. Janssen is a subsidiary of Johnson & Johnson.

In one study, 30% of patients with Q80K polymorphism in the placebo arm achieved SVR12, compared with 47% of the patients with Q80K in the therapy arm. Among patients without the polymorphism in the treatment arm, 78% achieved SVR12, the release said.

Jannsen maintains exclusive worldwide marketing rights to Olysio, except in the Nordic countries, where Medivir maintains these rights. A marketing authorization agreement for Olysio was submitted to the European Medicines Agency in April 2013.

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