To print: Select File and then Print from your browser's menu --------------------------------------------------------------------------------------- Title: FDA Approves Novantrone (Mitoxantrone) For Worsening Forms Of Multiple Sclerosis URL: http://www.pslgroup.com/dg/1E453A.htm Doctor's Guide October 13, 2000
SEATTLE, WA -- October 13, 2000 -- Immunex Corporation announced the approval by the U.S. Food and Drug Administration (FDA) of Novantrone® (mitoxantrone for injection concentrate) as the first therapy approved for secondary progressive multiple sclerosis (MS). Novantrone is now indicated for reducing neurologic disability and/or the frequency of clinical elapses in patients with secondary progressive, progressive relapsing or worsening relapsing-remitting MS. "The approval of Novantrone offers a new treatment option for people with secondary-progressive, progressive-relapsing MS, and worsening elapsing-remitting MS," said Dr. Stephen Reingold, vice president for research at the National Multiple Sclerosis Society. Immunex filed for expanded labeling for Novantrone for the treatment of patients with worsening MS on June 7, 1999, and was unanimously recommended for approval on January 28, 2000, by the FDA Peripheral and Central Nervous System Drugs Advisory Panel. The new MS indication is based on results from a 24-month Phase III clinical trial in which Novantrone, at a dose of 12 mg/m2, was administered by short IV infusion once every three months. This trial demonstrated that Novantrone had a statistically significant impact on prolonging time to first treated relapse and on delaying disability progression in patients with secondary progressive or progressive relapsing MS. There was also a significant reduction in the mean number of treated relapses. There was a significant reduction in the number of Novantrone patients who had new MS lesions seen on magnetic resonance imaging (MRI). "The approval of Novantrone offers new hope for people who otherwise would not have an approved treatment," said Donald Goodkin, M.D., Immunex senior clinical scientist. "Novantrone is to me just another word for hope," said Debbie Salazar, Novantrone patient. "I think it's wonderful that it's available." The most common side effects of Novantrone in patients with MS in clinical trials have been nausea, hair loss, bladder infections, changes in menstrual cycle, mouth sores, diarrhea, constipation, and changes in cardiac rhythm. Novantrone should not be used by people with serious heart problems, liver disease or certain blood disorders. Patients treated with Novantrone may develop serious heart problems. To measure potential changes to the heart, people taking Novantrone should have regular testing of their heart's ability to pump blood. Because of risk of injury to the heart, there is a limit on the total lifetime amount of Novantrone a person can receive. For most patients this is approximately eight to 12 doses over two to three years. Patients and their doctors should carefully keep track of how much Novantrone is administered. Novantrone can increase potential for infection. Prior to each dose of Novantrone, blood samples should be taken to check blood counts and liver function. Women who are pregnant, trying to become pregnant, or breastfeeding should not use Novantrone. Also, it is recommended that women who are biologically capable of becoming pregnant, even if they are using birth control, should have a pregnancy test prior to each dose. Multiple sclerosis is a chronic, often debilitating disease of the central nervous system that, in its various stages, affects over one third of a million people in the United States. The symptoms of MS result when a breakdown occurs in the myelin sheath, the fatty substance that insulates the nerve fibers of the brain and spinal cord. This demyelination process causes patches of scar tissue, or "sclerosis," which interfere with the nerve's ability to transport messages from the brain to body parts. This can result in a variety of symptoms that range from numbness in the limbs, to complete paralysis. Approximately half the 350,000 U.S. patients with MS will eventually develop active progressive forms of the disease, known as secondary progressive, progressive remitting and worsening relapsing-remitting MS. These conditions are characterized by: -- a progression of disability that significantly impacts functioning; or -- patients who are diagnosed with relapsing-remitting disease, in which their symptoms flare up and then ease or even disappear for months or years; or -- patients who are diagnosed with secondary progressive MS, in which their symptoms steadily worsen, as flares become more frequent and severe, and recovery is incomplete. 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. It is currently marketed, in combination with corticosteroids, to treat pain in patients with advanced hormone-refractory prostate cancer and for initial therapy of acute nonlymphocytic leukemia. Related links: Novantrone and Immunex Corporation. --------------------------------------------------------------------------------------------- Copyright © 1999 P\S\L Consulting Group Inc. All rights reserved. Republication or redistribution of P\S\L content is expressly prohibited without the prior written consent of P\S\L. 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