Company Seeks Priority Review of NOVANTRONE In Secondary Progressive
Multiple Sclerosis
SEATTLE, June 2 /PRNewswire/ -- Immunex Corporation (Nasdaq: IMNX) announced
today that it will file a supplemental NDA with the U.S. Food and Drug
Administration (FDA) for expanded labeling for NOVANTRONE(R) (mitoxantrone
for injection concentrate) for the treatment of patients with secondary
progressive Multiple Sclerosis (MS).
"There are 120,000 patients with secondary progressive MS for whom there are
still no approved treatment options," said Peggy V. Phillips, senior vice
president, pharmaceutical development for Immunex. "Patients with this form
of the disease experience a steady worsening of their neurological function
which can result in loss of control over movement of limbs and impaired
vision and speech. We are pleased to file this and we will ask the FDA for
priority review."
The results of the pivotal NOVANTRONE Phase III data submitted to the FDA
today showed that NOVANTRONE had a statistically significant impact on
relapse rate and disability progression in patients with secondary
progressive MS. These clinical data were corroborated by positive magnetic
resonance imaging (MRI) data.
This multicenter, placebo-controlled, randomized, observer-blind study of 194
patients compared two doses of NOVANTRONE -- 12 mg/m2 and 5 mg/m2 -- with
placebo. Each treatment was administered by short, IV infusion once every
three months for two years. These results were reported at the September 1998
Congress of the European Committee for Treatment and Research in Multiple
Sclerosis (ECTRIMS).
Additional third-year follow-up data were presented in April of this year at
the Annual Meeting of the American Academy of Neurology (AAN). These results
showed that one year after treatment was stopped, patients who had been
treated with NOVANTRONE experienced a sustained reduction in their number of
attacks, and delay in their disability progression, compared to patients
treated with placebo.
In the 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/m2 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).
Multiple sclerosis is a chronic, debilitating disease of the central nervous
system that afflicts 300,000 to 350,000 people in the United States. The
symptoms of MS result when inflammation and breakdown occur in myelin, the
fatty substance that insulates the nerve fibers of the brain and spinal cord.
This substance helps conduct the flow of nerve impulses to and from the
brain. In people with MS, the myelin is damaged, causing patches of scar
tissue, or "sclerosis," which interferes with the body's ability to transport
messages from the brain to body parts, thereby inhibiting body functions and
movement. This can result in a variety of symptoms that range from numbness
in the limbs to complete paralysis.
Approximately 120,000 MS patients in the U.S. have a form of the disease
classified as secondary progressive. These patients often are initially
diagnosed with relapsing-remitting disease, in which their symptoms flare up
and then ease or even disappear for months or years. Eventually, the
neurological function of patients who develop secondary progressive MS begins
to steadily worsen as flares become more frequent and severe, and recovery is
incomplete. There are currently no approved treatments in the United States
for people with secondary progressive MS.
Initial studies in animal models showed NOVANTRONE helped prevent disease
relapse and progression. These preclinical studies led to further studies of
NOVANTRONE in patients with MS. Several Phase I and II trials were conducted
that showed a reduction in new lesions on MRI, as well as reductions in the
number and severity of relapses in patients treated with NOVANTRONE.
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.
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.
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
CO: Immunex Corporation; U.S. Food and Drug Administration
ST: Washington
IN: MTC HEA
SU:
06/02/99 10:45 EDT http://www.prnewswire.com