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 Ph
Contact: Saundra Severtson