(Bloomberg) — Gilead Sciences Inc. won U.S. approval for the first all-oral hepatitis C treatment for the majority of people infected with the virus.
The Food and Drug Administration (FDA) cleared Gilead’s once-daily medicine that combines the active ingredient in the company’s Sovaldi with a drug called ledipasvir, the agency said today in a statement. The therapy was studied for its ability to cure patients in 12 weeks, four times faster than less effective 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. The form infects about 75 percent of people with the virus. Drugmakers are competing to develop hepatitis C therapies that don’t require use of interferon injections. The injections 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.
“With the development and approval of new treatments for hepatitis C virus, we are changing the treatment paradigm for Americans living with the disease,” said Edward Cox, director of the Office of Antimicrobial Products in the FDA’s Center for Drug Evaluation and Research. “Until last year, the only available treatments for hepatitis C virus required administration with interferon and ribavirin. Now, patients and health care professionals have multiple treatment options.”
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Gilead fell 2 percent to $103.73 at the close in New York.
About 3.2 million people in the U.S. have hepatitis C, according to the Centers for Disease Control and Prevention (CDC). The virus attacks the liver and can lead to cirrhosis or cancer. Both active ingredients in Gilead’s new pill inhibit the ability of the virus to replicate.
The FDA in November approved Olysio from Johnson & Johnson and Medivir AB. The therapy requires interferon injections though it works in 24 weeks, cutting interferon shots in half compared with older treatments that are given for 48 weeks.
The FDA approved Gilead’s Sovaldi in December as an all-oral treatment for some patients and for genotypes 1 and 4 as part of a cocktail including interferon injections and ribavirin. The cocktail cured 90 percent of patients in a clinical trial in 12 weeks that hadn’t been treated before.
Sovaldi’s $84,000 price tag for a 12-week course of treatment has attracted the ire of insurance companies and lawmakers who claim the cost makes the drug inaccessible for many who need it. For as many as half of genotype 1 patients who may benefit after just eight weeks of therapy, a Harvoni regimen will cost $63,000, Gilead said in an e-mail.