FDA Approves Janssen’s and Medivir’s Olysio With Sovaldi for Hepatitis C

The FDA has cleared Janssen and Medivir’s hepatitis C drug Olysio to be used in combination with Sovaldi, making it the latest drug to be paired up with Gilead Sciences’ blockbuster product.

Olysio (simeprevir) is approved for a 12 or 24-week treatment with Sovaldi (sofosbuvir) in patients with genotype 1 infections. The drug won approval last November for use with pegylated interferon and ribavirin.

The drugmakers supported the sNDA for Olysio/Sovaldi with data from a Phase II trial that found between 86 and 95 percent of patients on the 12-week regimen experienced functional cures 12 weeks after treatment. One hundred percent of patients with cirrhosis in the 24-week arm saw functional cures.

It’s difficult to know whether the new combination treatment will prove more tolerable or will eventually replace ribavirin and interferon, said Avi Prabhakar, Janssen’s hepatitis C director. He did point out, however, that the new regimen is all oral, whereas interferon requires a weekly injection.

In the U.S., a 12-week supply of Olysio costs $66,000, or $22,120 per bottle, a price that hasn’t changed since the launch one year ago, Janssen spokeswoman Lisa Vaga said.  The cost is below that of Sovaldi, which is $84,000 for a 12-week supply, and Gilead’s Harvoni (ledipasvir/sofosbuvir) formulation, which is $94,500 for 12 weeks.

Other drugs also have been indicated alongside Sovaldi, including Gilead Sciences’ ledipasvir and Bristol-Myers Squibb’s Daklinza (daclatasvir). — Lena Freund

Originally appeared in Drug Industry Daily, the pharmaceutical industry’s number one source for regulatory news and information. Click here for more information.