First Therapy Approved for Secondary Progressive Multiple Sclerosis (MS),
NOVANTRONE, Offers New Hope for Patients Whose MS Continues to Worsen
SEATTLE, Oct. 13 /PRNewswire/ -- Immunex Corporation (Nasdaq: IMNX) today
announced the approval by the U.S. Food and Drug Administration (FDA) of
NOVANTRONE(R) (mitoxantrone for injection concentrate) as the first therapy
approved for secondary progressive multiple sclerosis (MS). NOVANTRONE is now
indicated for reducing neurologic disability and/or the frequency of clinical
relapses in patients with secondary progressive, progressive relapsing or
worsening relapsing-remitting MS.
"The approval of NOVANTRONE offers a new treatment option for people with
secondary-progressive, progressive-relapsing MS, and worsening
relapsing-remitting MS," said Dr. Stephen Reingold, vice president for
research at the National Multiple Sclerosis Society.
Immunex filed for expanded labeling for NOVANTRONE for the treatment of
patients with worsening MS on June 7, 1999, and was unanimously recommended
for approval on January 28, 2000, by the FDA Peripheral and Central Nervous
System Drugs Advisory Panel.
The new MS indication is based on results from a 24-month Phase III
clinical trial in which NOVANTRONE, at a dose of 12 mg/m2, was administered by
short IV infusion once every three months. This trial demonstrated that
NOVANTRONE had a statistically significant impact on prolonging time to
first treated relapse and on delaying disability progression in patients with
secondary progressive or progressive relapsing MS. There was also a
significant reduction in the mean number of treated relapses. There was a
significant reduction in the number of NOVANTRONE patients who had new MS
lesions seen on magnetic resonance imaging (MRI).
"The approval of NOVANTRONE offers new hope for people who otherwise would
not have an approved treatment," said Donald Goodkin, M.D., Immunex senior
clinical scientist.
"NOVANTRONE is to me just another word for hope," said Debbie Salazar,
NOVANTRONE patient. "I think it's wonderful that it's available."
The most common side effects of NOVANTRONE in patients with MS in clinical
trials have been nausea, hair loss, bladder infections, changes in menstrual
cycle, mouth sores, diarrhea, constipation, and changes in cardiac rhythm.
NOVANTRONE should not be used by people with serious heart problems, liver
disease or certain blood disorders.
Patients treated with NOVANTRONE may develop serious heart problems. To
measure potential changes to the heart, people taking NOVANTRONE should have
regular testing of their heart's ability to pump blood. Because of risk of
injury to the heart, there is a limit on the total lifetime amount of
NOVANTRONE a person can receive. For most patients this is approximately 8 to
12 doses over 2 to 3 years. Patients and their doctors should carefully keep
track of how much NOVANTRONE is administered.
NOVANTRONE can increase potential for infection. Prior to each dose of
NOVANTRONE, blood samples should be taken to check blood counts and liver
function. Women who are pregnant, trying to become pregnant, or breastfeeding
should not use NOVANTRONE. Also, it is recommended that women who are
biologically capable of becoming pregnant, even if they are using birth
control, should have a pregnancy test prior to each dose.
About MS
Multiple sclerosis is a chronic, often debilitating disease of the central
nervous system that, in its various stages, affects over one third of a
million people in the United States. The symptoms of MS result when a
breakdown occurs in the myelin sheath, the fatty substance that insulates the
nerve fibers of the brain and spinal cord. This demyelination process causes
patches of scar tissue, or "sclerosis," which interfere with the nerve's
ability to transport messages from the brain to body parts. This can result
in a variety of symptoms that range from numbness in the limbs, to complete
paralysis.
Approximately half the 350,000 U.S. patients with MS will eventually
develop active progressive forms of the disease, known as secondary
progressive, progressive remitting and worsening relapsing-remitting MS.
These conditions are characterized by:
-- a progression of disability that significantly impacts functioning; or
-- patients who are diagnosed with relapsing-remitting disease, in which
their symptoms flare up and then ease or even disappear for months or
years; or
-- patients who are diagnosed with secondary progressive MS, in which
their symptoms steadily worsen, as flares become more frequent and
severe, and recovery is incomplete.
For more information about MS, contact The National Multiple Sclerosis
Society, at 800-Fight-MS (800-344-4867), visit their web site at http://www.nmss.org,
or visit http://www.msknowledge.com, an informational site sponsored by Immunex.
About NOVANTRONE
NOVANTRONE acts in people with MS by suppressing the activity of certain
white blood cells known as T cells, B cells and macrophages that are thought
to lead the attack on the myelin sheath. It is currently marketed, in
combination with corticosteroids, to treat pain in patients with advanced
hormone-refractory prostate cancer and for initial therapy of acute
nonlymphocytic leukemia. Full prescribing information for NOVANTRONE can be
obtained by calling 800-5-NOVANTRONE (800-566-8268) or by visiting
http://www.novantrone.com or http://www.immunex.com.
Immunex Corporation is a leading biopharmaceutical company dedicated to
improving lives through immune system science innovations.
American Home Products Corporation owns a majority interest in Immunex.
AHP is one of the world's largest research-based pharmaceutical and health
care products companies. It is a leader in the discovery, development,
manufacturing and marketing of prescription drugs, including biotechnological
and vaccine products, animal health care products and over-the-counter
medications.
NOTE: This news release contains forward-looking statements that involve
risks and uncertainties, including risks associated with clinical development,
regulatory approvals, our reliance on third-party manufacturers, product
commercialization and other risks described from time to time in the SEC
reports filed by Immunex, including the most recently filed Form 10-Q. An
electronic version of this news release -- as well as additional information
about Immunex of interest to investors, customers, future employees and
patients -- is available on the Immunex home page at http://www.immunex.com.
SOURCE Immunex Corporation
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