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 .
We hope this article was informative. Thank
you for taking the time to read
it.
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FDA Advisory Committee Recommends Approval of NOVANTRONE(R) For Treatment Of Worsening Multiple Sclerosis
Date: January 2000
NOVANTRONE Unanimously Recommended for Approval
GAITHERSBURG, Md., Jan. 28 /PRNewswire/ -- NOVANTRONE(R) (mitoxantrone for injection concentrate) was unanimously recommended for approval to slow the worsening of neurologic disability and to reduce the relapse rate in patients with clinically worsening forms of relapsing-remitting and secondary progressive multiple sclerosis (MS). This recommendation was made today by the U.S. Food and Drug Administration (FDA) Peripheral and Central Nervous System Drugs Advisory Panel. NOVANTRONE is marketed by Immunex Corporation (Nasdaq: IMNX).
Clinical results presented today by Immunex demonstrate that NOVANTRONE had a statistically significant impact on reduction of relapse rate and delay in disability progression in these patients. In a Phase III trial, there was a 65% reduction in annual relapse rate with NOVANTRONE compared to placebo and a 64% reduction in 1-point Expanded Disability Status Scale (EDSS) deterioration confirmed at 6 months. Positive magnetic resonance imaging (MRI) data were also presented that corroborate these clinical findings. NOVANTRONE, at a dose of 12 mg/m(2), was administered by short IV infusion once every three months for two years.
"These data demonstrate NOVANTRONE is clearly of benefit for a significant group of MS patients who currently have limited treatment options," said Hans-Peter Hartung, MD, Chairman, Department of Neurology Graz University, Austria and principal investigator of the pivotal NOVANTRONE Phase III study.
There are 350,000 MS patients in the U.S. and approximately half will eventually develop an active progressive form of the disease which is characterized by a progression of disability that significantly impacts functioning. At fifteen years after diagnosis, nearly 50% of secondary progressive MS patients require walking aids, and 10% need to use a wheelchair.
"The recommendation of the committee is an important step toward offering new hope to the people who struggle with this debilitating form of the disease," said Peggy Phillips, chief operating officer for Immunex. "We will continue to work closely with FDA officials to complete the review of our application."
In the Phase III study, treatment with NOVANTRONE resulted in generally manageable side effects that were primarily mild to moderate. During the two-year trial, the most frequent side effects reported by patients treated in the 12 mg/m(2) arm were nausea, alopecia (hair loss), upper respiratory tract infection, urinary tract infection, menstrual disorder, and transient neutropenia (a reduced number of white blood cells). No congestive heart failure was reported. Because of the potential for functional cardiac changes, Immunex has recommended that MS patients receiving NOVANTRONE should have cardiac monitoring and that treatment should be discontinued at a cumulative dose of 140 mg/m(2).
Today's recommendation by the Peripheral and Central Nervous System Drugs Advisory Panel, although not binding, will be considered by the FDA in its final review of the NOVANTRONE new drug application (NDA). The committee that reviewed the application is composed of experts in the field of neurology and is convened by the FDA to provide expertise and advice related to the review of drugs for neurological diseases such as MS.
Multiple sclerosis is a chronic, debilitating disease of the central nervous system that, in its various stages, afflicts as many as 350,000 people in the U.S. The symptoms of MS result when a breakdown occurs in the myelin sheath that insulates the nerve fibers of the brain and spinal cord, resulting in patches of scar tissue, or "sclerosis." When demyelination occurs, nerve impulses are slowed or halted which can cause symptoms ranging from numbness in the limbs to complete paralysis.
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.
NOVANTRONE is currently marketed to treat pain in patients with advanced hormone-refractory prostate cancer in combination with corticosteroids and for initial therapy of acute nonlymphocytic leukemia. It is not approved for use in MS patients. Full prescribing information for NOVANTRONE can be obtained by calling 800-IMMUNEX or visiting www.immunex.com.
Immunex Corporation is a biopharmaceutical company dedicated to developing immune system science to protect human health. The company's products offer hope to patients with cancer, inflammatory and infectious diseases.
American Home Products Corporation owns a majority interest in Immunex. AHPC is one of the world's largest research-based pharmaceutical and health care products companies and is a leading developer, manufacturer and marketer of prescription drugs and over-the-counter medications. It is also a leader in vaccines, biotechnology, agricultural products and animal health care.
This news release contains forward-looking statements that involve risks and uncertainties, including risks associated with clinical development, regulatory approvals, product commercialization and other risks described from time to time in the SEC reports filed by Immunex, including the most recently filed Form 10-K and 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 www.immunex.com.
SOURCE Immunex Corporation CONTACT: media, Tim Warner, 206-470-4193, or investors, Mark Leahy, 206-389-4363, both of Immunex Corporation
Source: MS-Highlights
NOVANTRONE Unanimously Recommended for Approval. ....(above article)
Novantrone getting closer to approval...
Mitoxantrone... generic name for Novantrone...
EUROPEAN STUDY: MITOXANTRONE MAY HELP SECONDARY-PROGRESSIVE MS
September 11, 1998
Summary: Preliminary results of a Phase 3 study of Novantrone
(mitoxantrone HCl for injection) were presented at the 14th Congress of
European Committee for Treatment and Research in Multiple Sclerosis in
Stockholm on September 9-12, 1998. Results suggest:
This potent immune-suppressing drug may reduce relapses and slow
disease progression in those with relapsing-remitting and
secondary-progressive MS. Full data analysis has not yet been
completed, and results have not yet been published to receive full
scrutiny by the medical community. Concerns about significant long-term
heart toxicity have been raised, and await further evaluation.
Details: Preliminary results of a Phase 3 study of Novantrone
(mitoxantrone HCl for injection), conducted at four European centers,
were presented at the 14th Congress of European Committee for Treatment
and Research in Multiple Sclerosis (ECTRIMS) in Stockholm on September
9-12, 1998. Immunex Corporation (Seattle) distributes this drug, which
is approved for use in some forms of cancer, in the United States.
The Drug: Mitoxantrone is a potent immune-suppressing drug that kills
B
and T lymphocytes (immune cells). It has been shown to prevent the
development of the MS-like disease EAE in rodents. In the U.S., the drug
is currently approved as therapy for non-lymphocytic leukemia in adults.
It is also approved for use in combination with corticosteroids as
chemotherapy for patients with pain related to advanced prostate cancer.
In other countries, mitoxantrone is approved for the treatment of
non-Hodgkin's lymphoma, breast cancer and hepatoma. Mitoxantrone has
been studied in MS in a number of smaller clinical trials in Europe and
North America, with modest results and some safety concerns reported.
The Trial: This Phase 3 study involved 188 patients with
relapsing-remitting or secondary-progressive MS. Patients received
intravenous mitoxantrone every three months for up to two years, or an
inactive placebo.
Results: Preliminary analysis of the results of the trial, performed
by
the drug company, suggests that mitoxantrone reduced the number of MS
attacks and reduced the number of active MS lesions (damaged areas)
apparent in MRI images enhanced with gadolinium. The drug also appears
to slow the progression of disability. Full data have not yet been
analyzed and have not yet been published for complete scrutiny, nor have
they been submitted to any drug regulatory authority for consideration
as an MS treatment.
Comments: These preliminary results suggest that mitoxantrone has
potential as a treatment for relapsing-remitting and
secondary-progressive MS. However, prior experience with mitoxantrone in
persons with MS and other disorders indicates that extended use of the
drug can lead to significant toxicity to the heart. It is unclear,
therefore, how long this drug can be used without major complications.
It is also unclear if mitoxantrone can be used safely and effectively in
combination with, or in sequence with, other approved MS medications.
Additional studies are needed to determine whether it is safe to use
mitoxantrone in MS for periods longer than two years, and to determine
if it can be used along with other MS treatments without increased side
effects.
The National Multiple Sclerosis Society will track information about
the
potential use of mitoxantrone in MS. We urge rapid publication of
relevant clinical data and a more complete assessment of the potential
for long-term risk of this agent.
1998 The National Multiple Sclerosis Society