GAITHERSBURG, MD -- NOVANTRONE (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/m2, 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/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). 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/m2.
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 1-800-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 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.