By Toni Clarke
WASHINGTON Oct 25 A federal advisory panel
recommended on Friday that the U.S. Food and Drug Administration
approve Gilead Sciences Inc's experimental hepatitis C
drug sofosbuvir, paving the way for a treatment that is more
effective than current therapies and takes less time.
The FDA advisory panel voted 15 to 0 in favor of approval of
the drug in patients with two variants of the liver-damaging
disease - genotype 2 and genotype 3 - in combination with an
existing treatment, ribavirin.
If approved, it will be the first all-oral treatment for
genotypes 2 and 3, obviating the need for the injectable drug
interferon, which can cause debilitating side effects. Panelists
called the vote "historic" and a "game-changer."
"Our patients have been waiting for this for a long time,"
said Dr. Curt Hagedorn, chief of medicine service at the Central
Arkansas Veterans Healthcare Service.
The panel also voted unanimously to approve the drug in
patients with genotype 1 and genotype 4 variants in combination
with ribavirin and interferon in patients who have not received
Genotype 1 accounts for roughly 70 percent of hepatitis C
cases. The FDA is not bound to follow the advice of its panels
but typically does so.
"We'd already built in 100 percent chance of approval into
our valuation for the company," said Karen Andersen, an analyst
at Morningstar. "Gilead is still really in the prime position
looking ahead in the hepatitis C market."
Panelists also appeared to support the use of sofosbuvir in
patients who failed prior treatment, even though the company has
little hard data to support such a claim.
"I did think there was a surprise upside result by the end
of the panel," said Michael Yee, an analyst at RBC Capital
Bristol-Myers Squibb Co and Abbvie Inc have
advanced all-oral clinical trial programs in late-stage
development, using a variety of so-called direct acting
antivirals, which directly interfere with the virus's ability to
replicate. But Gilead is widely seen to be in the lead.
Chronic hepatitis C affects at least 3 million people in the
United States, according to the U.S. Centers for Disease
Analysts on average expect Gilead's drug to generate sales
of $1.73 billion in 2014, according to Thomson Reuters data.
Current standard treatments for genotype 1 often include a
protease inhibitor. These are oral drugs that include Merck & Co
Inc's Victrelis and Vertex Inc's Incivek.
Gilead acquired sofosbuvir, known as a nucleotide analogue
inhibitor, with its $11 billion purchase of Pharmasset Inc in
Panelists urged Gilead to make the drug available to other
companies to study in combination with other oral regimens
waiting in the wings.
Bristol-Myers is expected to present data from a late-stage
clinical trial of its interferon-free treatment of genotype 1
patients at next month's meeting of the American Association for
the Study of Liver Diseases in Washington, D.C.
The FDA is due to rule on whether to approve the drug by