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U.S. approval for olysio plus sovaldi

Johnson & Johnson won U.S. approval for its hepatitis C drug Olysio to be used in combination with Gilead Sciences’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 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.

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.”

Patient Population

About 3.2 million people in the U.S. have hepatitis C, which can cause liver cirrhosis according to the Centers for Disease Control and Prevention. The most common form of the virus is genotype 1, which affects about 75 percent of patients. J&J, based in New Brunswick, New Jersey, and Swedish drugmaker Medivir AB (MVIRB) sell Olysio. The drug, in combination with ribavirin and interferon, can treat patients in 24 weeks, half the time of older medicines.

Read more... http://www.businessweek.com/news/2014-11-05/j-and-j-wins-u-dot-s-dot-approval-for-hepatitis-c-combo-with-gilead