FDA Approves Roche Hepatitis C Drug
- FDA Approves Roche Hepatitis C Drug
Tue Dec 3,10:53 PM ET
WASHINGTON (Reuters) - The U.S. Food and Drug Administration (news -
web sites) said on Tuesday it had approved Roche Holding AG's Pegasys
drug in combination with another anti-viral compound to treat
hepatitis C, a potential blockbuster product for the Swiss-based
Up to 4 million Americans are estimated to be infected with the
hepatitis C virus that slowly attacks the liver and sometimes kills.
An FDA advisory panel last month unanimously recommended approval of
Pegasys in combination with the antiviral drug ribavirin. The FDA
normally follows the recommendations of its advisory panels.
Pegasys is a once-a-week, long-acting, injectable version of the
antiviral protein interferon, and daily doses of Copegus, Roche's
version of the ribavirin pill.
The FDA in October gave Pegays clearance as a stand-alone treatment
for hepatitis C but approval for the combination is seen as crucial
for Roche to compete with a similar combination therapy by
Pegasys has already received European approval for use alone or in
combination with ribavirin.
"Today, Roche can proudly offer Americans with hepatitis C a new
treatment choice," Hoffmann Roche Inc. President and Chief Executive
Officer George Abercrombie said in a statement.
The drug is especially important for Roche which industry analysts
says has a relatively thin new-product pipeline.
Roche, which has climbed back into the ranks of the world's top 10
drugmakers by acquiring Japan's Chugai Pharmaceutical Co. Ltd. this
year, is counting on Pegasys and HIV (news - web sites) drug Fuzeon
to help it generate double-digit 2003 drug sales growth.
Roche drugs division head William Burns told Reuters last month he
expects sales of its Pegasys drug combined with ribavirin to build
slowly toward $1 billion a year over three to five years once it wins
Hepatitis C is biggest cause of liver transplants in the United
States but the disease develops slowly, often over 20 years, before
symptoms of liver failure emerge.
Schering-Plough's rival long-acting interferon, called Peg-Intron, is
also given weekly by injection, with patients also taking daily
Sales of Peg-Intron and Schering-Plough's brand of ribavirin more
than doubled to $703 million in the third quarter, making hepatitis C
the company's biggest business.
Patients flocked to Schering-Plough's dual therapy after it was
launched in October 2001 because it is more effective and causes
fewer side effects than the company's older treatment using an
interferon that had to be taken three times a week.
Schering-Plough's improved therapy is considered the "gold standard"
of treatment, with about 56 percent of patients taking it eliminating
all traces of hepatitis C after 48 weeks of medication.
With Roche's Pegasys combination, 50 percent of people having no
detectable virus in their blood six months after treatment concluded,
Roche officials told the FDA advisory panel last month. Using an
older interferon, injected three times a week, with ribavirin, only
42 percent of patients cleared the virus.
With Pegasys alone, the treatment was effective in 27 percent of
Roche is also testing Pegasys against hepatitis B, a form of the
disease that is a large problem in Asia.
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