U.S. Food and Drug Administration Issues 'Approvable Letter' in Support
Of NOVANTRONE(R) to Treat Multiple Forms of Multiple Sclerosis
SEATTLE, March 2 /PRNewswire/ -- The U.S. Food and Drug Administration
(FDA) issued an "approvable letter" to Immunex Corporation (Nasdaq: IMNX)
today, indicating the agency's intention to support the use of NOVANTRONE(R)
(mitoxantrone for injection concentrate) to treat multiple forms of multiple
sclerosis (MS).
The "approvable letter" issued today follows a recommendation for approval
made last month by the FDA's Peripheral and Central Nervous System Drugs
Advisory Panel.
"The FDA's 'approvable letter' brings physicians and their patients with
MS one step closer to gaining access to this new approach to treating
worsening forms of this disease," said Dawn Viveash, vice president,
regulatory affairs. "Our productive interaction with the FDA will continue,
as we work with officials of the agency to expeditiously fulfill the
requirements of the approval process. We expect the new NOVANTRONE labeling
to be consistent with the FDA panel's recommendations for treatment
indications and safety."
Physicians and patients will be advised that the use of NOVANTRONE has
been associated with cardiotoxicity. This risk increases with cumulative dose
and patients should be monitored for evidence of cardiotoxicity. Ordinarily,
MS patients should not receive a cumulative dose greater than 140mg/m2. In
the two-year clinical trial of patients with MS, side effects were generally
manageable and primarily mild to moderate. The most frequently reported
adverse events in patients receiving 12mg/m2 were nausea, alopecia (hair
loss), upper respiratory tract infection, urinary tract infection, menstrual
disorder, and transient neutropenia (a reduced number of white blood cells).
Multiple sclerosis is a chronic, debilitating disease of the central
nervous system. 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 http://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.
NOTE: 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
http://www.immunex.com.
SOURCE Immunex Corporation
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CONTACT:
media, Tim Warner, 206-470-4193, or
investors, Mark Leahy, 206-389-4363, both of Immunex Corporation
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