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

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

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 sell Olysio. The drug, in combination with ribavirin and interferon, can treat patients in 24 weeks, half the time of older medicines.

J&J, the world’s largest health-care products company, reported Olysio revenue of almost $2 billion in the first three quarters of this year. Sovaldi has generated $8.6 billion in sales during the same time period.

Patients have been able use J&J’s Olysio and Gilead’s Sovaldi together without FDA clearance at a cost of $150,000. Doctors may prescribe drugs approved for specific diseases to treat other ailments in a practice called off-label use.

The drugs are part of a push to shorten treatment times while improving cure rates and eliminating unpleasant side effects. Older drugs include Merck & Co.’s Victrelis and Vertex Pharmaceuticals Inc.’s Incivek.

The FDA approved the combination treatment for a standard 12 weeks of therapy if patients don’t have cirrhosis and 24 weeks for those who do, according to the drug’s prescribing label.

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