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Pharmaceuticals / Regulatory Affairs / Submissions and Approvals

Next-Generation Hep C Drugs Clear Key Regulatory Hurdles in U.S., EU

Nov. 26, 2013

Two new hotly anticipated hepatitis C drugs expected to change the way the disease is treated, one developed by Gilead and another by Janssen/Medivir, cleared key regulatory hurdles Friday.

The FDA approved Janssen and Medivir’s Olysio (simeprevir), an NS3/4A protease inhibitor, to treat chronic hepatitis C virus (HCV) infection in combination with pegylated interferon and ribavirin in genotype 1 infected adults with compensated liver disease, including cirrhosis. The drug is the first protease inhibitor indicated for the treatment of chronic HCV infection to be approved for once-daily dosing in a combination antiviral regimen, according to the drugmakers.

The drug has the potential to cure chronic HCV, which affects some 3.2 million people in the U.S., Douglas Dieterich, Mount Sinai School of Medicine and an Olysio clinical investigator, said. Janssen has developed a patient outreach program called Olysio Support to educate patients and caregivers about the product.

Analysts don’t expect simeprevir to reach blockbuster status, but do predict fast adoption by patients seeking treatment alternatives. Doctors on an FDA advisory panel have praised the drug.

Also on Friday, the European Medicines Agency’s Committee for Medicinal Products for Human Use recommended marketing authorization for Sovaldi (sofosbuvir), Gilead’s Hep C drug candidate proposed to treat chronic HCV in adults in combination with other medicines.

The FDA’s Antiviral Drugs Advisory Committee last month voted unanimously (15-0) that the available data support the drug’s approval. Sofosbuvir has a PDUFA decision date of Dec. 8.

While proposed for use in combination with other agents, both drugs move patients away from interferon-based therapies, which are known to cause serious side effects. — Johnathan Rickman

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