|
 Gilead said in a separate statement that it priced the drug at
$74,760 for a 12-week regimen.
Gilead has dominated the hepatitis C market over rivals AbbVie and
Merck & Co with its high-priced and highly effective treatments
Sovaldi and the combination drug Harvoni. The new treatment, to be
sold under the brand name Epclusa, combines Sovaldi (sofosbuvir),
which was approved in 2013, with a new anti-viral drug velpatasvir.
Epclusa costs less than the $84,000 that Sovaldi sold for when it
launched in late 2013. Gilead now offers discounts and rebates on
that older drug, which was at the center of a national uproar over
soaring drug costs.
Epclusa is approved for patients with and without cirrhosis, a form
of scarring seen in patients with advanced disease that can lead to
liver failure and need for a transplant. For those with moderate to
severe cirrhosis, Epclusa must be taken with the older drug
ribavirin, the Food and Drug Administration said.
"This approval offers a management and treatment option for a wider
scope of patients with chronic hepatitis C," Edward Cox, director of
the FDA's Office of Antimicrobial Products, said in a statement.
While the majority of U.S. patients have the genotype 1 form of
hepatitis C, about 20 percent to 25 percent have genotypes 2 or 3,
with small numbers infected with genotypes 4, 5 or 6. In other parts
of the world, other genotypes are far more prevalent, such as in
Egypt, where genotype 4 is widespread.
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In pivotal clinical trials, Epclusa led to cure rates of 95 percent
to 99 percent in patients without or with mild cirrhosis after 12
weeks of treatment. In a separate trial of patients with moderate to
severe cirrhosis, cure rates of 94 percent were seen.
In afternoon trading, Gilead shares were up $3.35, or 4.28 percent
at $81.60 on Nasdaq.
(Reporting by Bill Berkrot in New York and Shailesh Kuber in
Bengaluru; Editing by Bill Trott and Diane Craft)
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