FDA Approves Viral Hepatitis Medication
Sales of New Drug May Generate $200 Million
Annually for Gilead Sciences
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By Justin Gillis
The Food and Drug Administration last night approved a long-awaited drug
for a form of viral hepatitis, expanding treatment options for a disease
that afflicts more than 1 million Americans.
The action was a significant boost for Gilead Sciences Inc., a Foster
City, Calif., biotechnology company that has built a strong portfolio of
antiviral drugs. Gilead already sells one of the country's fastest-growing
AIDS treatments, and analysts have said the new hepatitis B drug, known as
Hepsera or adefovir dipivoxil, could bring revenue of $200 million a year or
more.
Hepatitis is a slow-to-develop but life-threatening ailment that can lead
to cancer or catastrophic liver failure. Many liver doctors had been
awaiting the action the FDA took last night. Unsatisfied with two drugs
already on the market, which have severe limitations, the doctors held off
treatment for many patients healthy enough to wait. They also had been
seeking a new treatment for seriously ill patients who have exhausted all
other options.
"It works dramatically" in many patients for whom another antiviral drug,
lamviudine, has stopped working, said Eugene Schiff, head of the Center for
Liver Diseases at the University of Miami School of Medicine and a
consultant to Gilead. "It's not a perfect drug, but there's no question it's
an advance in hepatitis B."
The new drug is one of a growing number of spinoffs from the nation's
investment in AIDS research. It was originally developed as an AIDS drug but
proved too toxic in that use and was turned down by the FDA. However, it
proved effective against the hepatitis B virus at far lower, and therefore
safer, doses. It works by blocking reproduction of the virus.
A panel of experts that reviewed the drug for the FDA this summer noted
that it poses a risk of kidney damage, particularly in patients who use it
for a long time, and requires careful monitoring.
But the panel, mindful that hepatitis patients have relatively few
options for treatment, voted unanimously to recommend approval.
The FDA action is likely to boost the profile of Gilead, one of a handful
of American biotechnology companies that has graduated from the start-up
phase to become profitable. The FDA's decision was disclosed after the stock
market closed last night.
John Martin, Gilead's president and chief executive, said in a statement
that the company was "proud to have developed a drug with the profile of
Hepsera that will help to address the unmet medical needs of people living
with chronic hepatitis B."
© 2002 The Washington Post Company
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