J&J Wins U.S. Approval for Hepatitis C Combo With Gilead

Johnson & Johnson (JNJ:US) won U.S. approval for its hepatitis C drug Olysio to be used in combination with Gilead Sciences Inc. (GILD:US)’s Sovaldi, making it the second all-oral treatment available for the most common form of the virus.

The Food and Drug Administration cleared the once-daily treatment for patients with hepatitis C genotype 1, J&J said today in a statement. The combination allows Olysio to be used without the standard therapies including ribavirin and interferon, which are injections that have flu-like side effects.

The price of hepatitis C treatments has been criticized by insurers and lawmakers since Foster City, California-based Gilead’s Sovaldi was approved in December with an $84,000 price tag for a full course of treatment. The FDA on Oct. 10 cleared Gilead’s Harvoni, a once-daily pill that treats patients with the most common form of the virus without ribavirin or interferon at an estimated cost of $94,500 for 12 weeks.


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