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Article in Reuters dated October 13, 2000.....
WASHINGTON (Reuters) - Biotechnology company Immunex
Corp. IMNX.O won permission Friday to promote its cancer-fighting drug
Novantrone to treat advanced forms of multiple sclerosis (MS).
The drug is the first government-approved treatment
for a certain type of late-stage MS, a debilitating disorder of the central
nervous system that afflicts about 350,000 Americans.
MS symptoms include weakness, impaired vision,
loss of balance, poor muscle coordination and paralysis.
The Food and Drug Administration approved the injectable
Novantrone for treating various worsening types of MS known as secondary
progressive, progressive relapsing and worsening relapsing-remitting. Clinical
trials of about 200 patients showed Novantrone could reduce the number
of relapse episodes and slow the progression of disability.
"The approval of Novantrone offers new hope for
people who otherwise would not have an approved treatment," said Immunex
senior clinical scientist Donald Goodkin.
Shares of Seattle-based Immunex climbed 11.6 percent,
closing 4-3/8 higher at $42.
The FDA warned that some patients treated with
Novantrone may develop serious heart problems. MS patients normally should
not receive more than 8 to 12 doses over two to three years and should
have regular heart and blood tests, the FDA said. Treatment is given once
every three months.
The most frequent side effects were nausea, hair
thinning, loss of menstrual periods, bladder infections and mouth sores.
Novantrone, known generically as mitoxantrone,
has been sold in the United States since 1987 as part of a chemotherapy
regimen for attacking leukemia. Novantrone sales last year were about $45
million.
Some doctors already have used Novantrone to treat
MS patients, but the FDA approval gives Immunex freedom to promote the
drug specifically for MS.
Novantrone works in MS by suppressing the white
blood cells believed to lead the immune system's attack on the protective
sheath that surrounds nerve fibers in the brain and nervous system.
Three other drugs are approved for early stages
of MS, Biogen Inc.'s BGEN.O Avonex, Betaseron by Chiron Corp. CHIR.O and
Copaxone by Teva Pharmaceutical Industries TEVA.O .
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EraseMS.com team