Hepatitis C Drug Simeprevir Approved by EU Regulators

A Swedish pharmaceutical company has been granted approval by the European Commission to market the drug simeprevir for the treatment of genotype 1 and 4 chronic hepatitis C infection.

Medivir AB announced that the drug, marketed under the name Olysio, will be used in a new triple therapy option prescribed with or without ribavirin and in combination with sofosbuvir. The all-oral regimen does not require pegylated interferon (PegIFN), a traditional hepatitis C treatment of an injectable drug often known for severe side effects.

Hepatitis C is a blood borne virus that can cause inflammation of the liver and lead to cirrhosis, cancer of the liver and a need for transplants in some patients. Health officials estimate that about 3 million people in the U.S and up to 150 million worldwide have chronic infection of the hepatitis C virus. It has been called the silent killer because an estimated 75% of people who have the virus don’t know it and may not have symptoms for many years until the liver is severely damaged.

“The approval of simeprevir in Europe is a further step in our partner's global strategy to enable an improved treatment for hepatitis C patients,” Medivir CEO Maris Hartmanis said in a news release. “This also means that Medivir will now be able to offer this treatment to patients in the Nordic region, where we have the marketing rights.”

Jointly developed by Medivir and Janssen R&D Ireland, simeprevir is a protease inhibitor that blocks a protein needed by the hepatitis C virus to replicate. The FDA approved the drug late last year for use in the US with the combination PegIFN and ribavirin for adults with genotype 1 infection with compensated liver disease, including cirrhosis. Sofosbuvir is a polymerase inhibitor that was also approved in 2013 and is marketed under the trade name Solvaldi by Gilead Sciences, Inc.

The European approval is a “significant milestone” in the development of new triple therapy treatment options for people with genotype 1 and 4 hepatitis C infection, states the company release. It includes simeprevir as part of a once-daily 12 week direct-acting antiviral regimen with or without ribavirin for patients who are intolerant of or ineligible to receive interferon treatment -- for 24 weeks with interferon and ribavirin for patients who had not been previously treated or had relapsed -- and for 48 weeks total for patients known to be nonresponders.

In seeking approval for simeprevir use in the European Union, Medivir submitted data from three pivotal phase 3 clinical trials (Quest-1, Quest-2, and PROMISE) involving more than 1000 patients, according to the release.The studies investigated the use of simeprevir in combination with PegIFN and ribavirin for patients who had not previously been treated and others who relapsed after prior interferon-base treatment.

The primary endpoint to achieve significant sustained virological response rates compared with PegIFN and ribavirin alone were met for all three studies.Common adverse events were nausea, rash, pruritus, dyspnea, increased blood bilirubin, and photosensitivity reaction.

In the US, Olysio is marketed by Janssen, which earlier this month submitted a supplemental New Drug Application to the FDA for once-daily use of simeprevir in combination with sofosbuvir for the treatment of genotype 1 chronic hepatitis C in adult treatment-naive patients with advanced fibrosis and null responders with all stages of liver fibrosis.

Janssen expects simeprevir to be available in European Union countries in the second half of 2014, according to a company release. The drug also been approved for hepatitis C treatment in Japan, Canada and, most recently, Russia, according to a Janssen.