A second potential blockbuster drug from Gilead Sciences to treat hepatitis C has been approved by the Food and Drug Administration. But at a cost of nearly $100,000 for a full course of treatment, the drug is certain to spark further debate over the pricing of specialty drugs.
The agency approved Harvoni following three clinical trials and an expedited review process because of the drug's potential for curing the liver disease. The trials showed that 94% of patients had no evidence of the virus in their bloodstream after 12 weeks of treatment with Harvoni and 99% of patients were cured after 24 weeks of treatment.
“Unlike other serious chronic diseases, hepatitis C can be cured and Harvoni offers patients the potential for a cure in as little as eight weeks,” John Martin, Gilead Sciences CEO, said in a news statement.
In December 2013, the FDA approved Sovaldi for treatment of hepatitis C. In the first half of this year, Gilead Sciences racked up $6 billion in sales, making it the most successful drug launch in U.S. pharmaceutical industry history.