FDA approves new hepatitis C drug, Harvoni

Insurers and patients are decrying the cost for the new drug, nearly $95,000 for a 12-week course of treatment, which is more expensive than Gilead's other hepatitis C drug, Sovaldi. But unlike some hepatitis C treatments, Harvoni can be taken without injections usually given to hepatitis C patients.

The New York Times: Harvoni, A Hepatitis C Drug From Gilead, Wins F.D.A. Approval
The first complete treatment for hepatitis C that requires taking only a once-a-day pill won approval Friday from the Food and Drug Administration. The drug, called Harvoni from Gilead Sciences, could shorten the duration of treatment and provide the first all-oral regimen for many patients. The new drug also appears to be a bit less expensive for some patients than Gilead's existing blockbuster hepatitis C drug, Sovaldi, which has become the poster child for those complaining that the cost of medicines is out of control. Sovaldi costs $1,000 a pill, or $84,000 for a typical 12-week course of treatment, but it must be used with other drugs. Harvoni is even more expensive at $1,125 a pill, or $94,500 for a 12-week course of treatment (Pollack, 10/10).

The Wall Street Journal: Gilead Gets U.S. Approval To Sell New Hepatitis C Drug
Gilead Sciences Inc. won U.S. approval Friday to begin selling the first pill that promises to cure most hepatitis C patients without requiring other medicines, but its near $100,000 cost will likely further inflame tensions between drug companies and health insurers over spiraling prices. ... The escalating price for treating hepatitis C, which affects more than three million Americans, has been a sore point for health insurers and drug-benefit managers facing a mounting dilemma: how to balance use of a medicine that can prevent tens of thousands of deaths without breaking the bank (Rockoff, 10/10).

Reuters: Gilead Wins U.S. Approval For Hepatitis C Combo Pill
Gilead Sciences Inc. (GILD) won U.S. approval for the first all-oral hepatitis C drug for the majority of people infected with the virus, potentially marking an end to injections as a mainstay of treatment. The Food and Drug Administration cleared Gilead's once-daily medicine that combines the active ingredient in the Foster City, California-based company's Sovaldi with a drug called ledipasvir, the agency said yesterday in a statement. The therapy was studied for its ability to cure patients in 12 weeks, four times faster than older treatments, and some can be treated in eight weeks, Gilead said in a statement. It will cost $94,500 for a typical 12-week treatment. The FDA approved the pill, which Gilead will call Harvoni, for patients with genotype 1 hepatitis C, the most common form that infects about 75 percent of people with the virus. Drugmakers are competing to develop hepatitis C therapies that don't require the use of interferon injections that can cause flu-like symptoms. Gilead's Harvoni is the first that can treat the vast majority of patients without injections or another standard therapy called ribavirin, the FDA said (Edney, 10/11).

San Francisco Chronicle: Is $1,125 Hepatitis Pill From Bay Area Drugmaker Worth It?
After shaking up the health care industry with a $1,000 hepatitis C pill, Gilead Sciences of Foster City won approval Friday for a new version of that treatment that works faster, drops the usual injections and boasts an already-controversial $1,125 price tag. The new daily pill Harvoni costs $94,500 for 12 weeks and $63,000 for eight weeks -- both cheaper than some existing hepatitis C treatments, according to the drugmaker. But some patient advocates are already upset about the price after nearly revolting against Gilead's first hepatitis C therapy, Sovaldi, which became the best-selling new drug ever when it hit the market late last year at $84,000 for 12 weeks. Harvoni, which combines Sovaldi and a new drug called ledipasvir, is expected to push Gilead's overall hepatitis C drug sales to $12 billion this year and more than $15 billion next year, said Michael Yee, a biotechnology analyst at RBC Capital Markets (Lee, 10/11).