Janssen Therapeutics has received approval from the US Food and Drug Administration (FDA) for an NS3/4A protease inhibitor, Olysio (simeprevir), to treat chronic hepatitis C infection as part of an antiviral treatment for genotype 1 infected adults with compensated liver disease, including cirrhosis.
According to the company, Olysio is expected to benefit patients with chronic hepatitis C, including those who are treatment-naïve or for have had previously ineffective treatment.
Chronic hepatitis C is a blood-borne infectious disease of the liver that affects about 3.2 million people in the US.
Olysio works by blocking the viral protease enzyme that allows the hepatitis C virus (HCV) to replicate in host cells.
The main goal of the treatment for chronic hepatitis C is cure, also called sustained virologic response (SVR), is defined as undetectable levels of HCV in the patients’ blood 12 to 24 weeks after the end of treatment.
A fixed treatment regimen of 12 weeks of Olysio, combined with 24 weeks of pegylated interferon and ribavirin, is recommended for treatment-naïve and prior-relapser patients; while for prior partial and null-responder patients, a treatment regimen of 12 weeks of Olysio combined with 48 weeks of pegylated interferon and ribavirin is recommended.
Mount Sinai School of Medicine professor of medicine in the division of liver diseases Douglas Dieterich said that given the complexity of the condition, Olysio was studied in a number of different patient populations, including individuals who have relapsed or failed to respond to previous treatments.
"The FDA approval of Olysio is an important milestone for people living with chronic hepatitis C as it means that patients have a new treatment option with the potential to cure this challenging disease," Dieterich said.
Olysio is a prescription medicine and must not be taken alone, while its efficacy in combination with peginterferon and ribavirin is greatly decreased in patients who have genotype 1a Q80K, according to Janssen Therapeutics, a division of Janssen Products (Janssen).
Janssen Research & Development has submitted the new drug application (NDA) to the FDA for Olysio, based on efficacy and safety results from three Phase III studies, including QUEST-1 and QUEST-2 in treatment-naïve patients, and PROMISE in patients who have relapsed after prior interferon-based treatment, as well as data from the Phase IIb ASPIRE trial in prior non-responder patients.
In each of the studies, Olysio was evaluated by dosing once daily in combination with pegylated interferon and ribavirin versus treatment with placebo plus pegylated interferon and ribavirin.
Janssen has also launched Olysio Support, which is a comprehensive support programme designed in partnership with the HCV community, to help assist patients and caregivers and their healthcare providers in hepatitis C treatment.
Olysio is being jointly developed by Janssen R&D Ireland and Medivir under an agreement, which will involve Janssen being responsible for the global clinical development of the drug and has exclusive, worldwide marketing rights, except in the Nordic countries where Medivir will retain marketing rights.