В США одобрена новая комбинированная терапия против гепатита С

Johnson & Johnson (JNJ) won U.S. approval for its hepatitis C drug Olysio to be used in combination with Gilead Sciences Inc. (GILD)’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 yesterday in a statement. The combination allows Olysio to be used without the standard therapies including interferon, an injection that sometimes has 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 who have the most common form of the virus without using the older drugs. Harvoni has an estimated cost of $94,500 for 12 weeks.

J&J hasn’t changed the $66,000 price for 12 weeks of therapy with Olysio since it was first cleared for use with older medicines in the U.S. a year ago, said Rebecca Tillet, a company spokeswoman. J&J plans to work with insurance companies and other payers to ensure it continues to provide access to patients, she said in a telephone interview.

“There are a lot of different patients needs,” she said. “We think Olysio will play a meaningful role in that mix.”