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Home | Clinical Trials

FDA Approved Drugs » 2000
Medical Areas: Neurology | Family Medicine

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Novantrone (mitoxantrone hydrochloride)

The following drug information is obtained from various newswires, published medical journal articles, and medical conference presentations.

Company: Immunex
Approval Status: Approved October 2000
Treatment Area: Reduction of neurologic disability and/or the frequency of clinical relapses in patients with multiple sclerosis

General Information

Novantrone has been approved for use in reducing neurologic disability and/or the frequency of relapses in patients with secondary (chronic) progressive, progressive relapsing, or worsening relapsing-remitting multiple sclerosis (i.e., patients whose neurologic status is significantly abnormal between relapses). Novantrone is not indicated for the treatment of patients with primary progressive multiple sclerosis.

White blood cells can produce the symptoms of multiple sclerosis by attacking myelin, a fatty substance that surrounds nerve cells. Novantrone suppresses the activity of T and B cells, and in this manner slows the progression of the disease and reduces the frequency of relapses.

Multiple sclerosis is diagnosed in over 350,000 people in the United States. There is no one group of people who "get" multiple sclerosis; however, trends show that it often strikes between the ages of 30 and 50, and affects mostly women. Multiple sclerosis is most commonly found in Canada, the United States, South America, and Europe. (from the Multiple Sclerosis Foundation)

Clinical Results

The safety and effectiveness of Novantrone in multiple sclerosis were assessed in two randomized, controlled multicenter trials. One trial was conducted in subjects with secondary progressive or progressive relapsing multiple sclerosis. Neurological disability was evaluated based on the Kutzke Expanded Disability Status Scale (EDSS). This scale ranges from 0.0 to 10.0, with increasing scores indicating worsening condition. Subjects receive a placebo, 5 mg/m2 Novantrone, or 12 mg/m2 Novantrone administered intravenously every three months for two years. At 24 months, the mean EDSS change (month 24 value minus baseline) was 0.23 for the placebo group, -0.23 for 5 mg/m2, and -0.13 for 12 mg/m2.

A second trial evaluated Novantrone in combination with methylprednisolone (MP) and was conducted in subjects with secondary progressive or worsening relapsing-remitting multiple sclerosis who had residual neurological deficit between relapses. A total of 42 subjects received monthly treatments of 1g of intravenous MP alone or approximately 12 mg/m2 of intravenous Novantrone plus 1 g of intravenous MP for six months. Subjects were evaluated monthly, and study outcome was determined after six months. The primary measure of effectiveness was a comparison of the proportion of subjects in each treatment group who developed no new Gd-enhancing MRI lesions at six months. Thirty-one percent of subjects receiving MP alone were without new Gd-enhancing lesions on MRIs, while 90% of subjects receiving Novantrone plus MP were without lesions. (from Novantrone Package Insert)

Side Effects

Possible adverse events associated with Novantrone include (but are not limited to) the following:


  • Nausea
  • Hair loss
  • Hypotension (low blood pressure)
  • Rashes
  • Urinary tract infection
  • Menstrual disorder

Mechanism of Action

Mitoxantrone, a DNA-reactive agent that intercalates into deoxyribonucleic acid (DNA) through hydrogen bonding, causes crosslinks and strand breaks. Mitoxantrone also interferes with ribonucleic acid (RNA) and is a potent inhibitor of topoisomerase II, an enzyme responsible for uncoiling and repairing damaged DNA. It has a cytocidal effect on both proliferating and nonproliferating cultured human cells, suggesting lack of cell cycle phase specificity.

Novantrone has been shown in vitro to inhibit B cell, T cell, and macrophage proliferation and impair antigen presentation, as well as the secretion of interferon gamma, TNFa, and IL-2.

Additional Information

For additional information on Novantrone, please visit the web site of Immunex Corporation.


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