FDA grants approval to Olysio from Janssen Therapeutics

TITUSVILLE, N.J. — Janssen Therapeutics announced earlier this week that the Food and Drug Administration approved Olysio (simeprevir), a hepatitis C virus NS3/4A protease inhibitor, in combination with sofosbuvir as an all-oral, interferon- and ribavirin-free treatment option for genotype 1 chronic hepatitis C (CHC) infection in adult patients as part of a combination antiviral treatment regimen. 

 

HCV is a blood-born infectious disease of the liver that affects more than three million people in the United States, according to the Centers for Disease Control and Prevention. Seventy-five percent to 85% of people infected with HCV develop chronic infection. Most people with CHC infection do not show symptoms of the disease, but when it is left untreated, the infection may cause significant liver damage. 

 

“It’s a very encouraging time for patients with chronic hepatitis as the advent of new direct-acting treatment combinations like Olysio plus sofosbuvir offer all-oral, interferon- and ribavirin-free treatment options,” said Eric Lawitz, M.D., VP, scientific and research development, the Texas Liver Institute and professor of medicine, University of Texas Health Science Center. “The availability of multiple treatment options is important to physicians and patients so optimal treatment decisions can be made, given the complexity of the disease and diversity of patient population.”