Novantrone Receives FDA Approval As MS Treatment
Tens of thousands of people in the United States with worsening forms of multiple sclerosis (MS) now have a new drug treatment available. Immunex has received approval from the Food and Drug Administration to market Novantrone for treatment of MS including secondary progressive, worsening relapsing-remitting, and progressive relapsing forms of this disease. These worsening forms of MS are often debilitating causing patients to experience deteriorating physical and mental capabilities.
Debbie Salazar is a MS patient who must depend on a cane to keep her balance when she walks. She was diagnosed 3 years ago with multiple sclerosis. The immune system of MS patients attacks the central nervous system rapidly taking independence from it's victims. Debbie now must plan ahead for even the most basic tasks such as shopping--making sure that the places she visits have scooters available for her to ride around.
Debbie tried many treatments to control the effects of MS but had limited success until her doctor suggested she try Novantrone--a drug that showed promise in studies of patients with worsening forms of MS. She is pleased with Novatrone and said "I go once every three months. Once that's done and over with it's.. I forget about it. I don't have to plan anything into my life as far as medication is concerned."
MS is a chronic disease of the central nervous system that affects over one-third of a million people in the United States. Symptoms 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.
About 175, 000 MS patients in the US will eventually develop active progressive forms of the disease. The progressive forms are known as secondary progressive, progressive remitting and worsening relapsing-remitting MS. Signs of these worsening forms include:
- 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.
"The approval of Novantrone offers a new treatment option for people with secondary-progressive, progressive-relapsing MS, and worsening relapsing-remitting MS." said Dr. Stephen Reingold, vice president for research at the National Multiple Sclerosis Society.
Novantrone was approved by the FDA based on the results of a large clinical trial in which the drug had a statistically significant impact on prolonging the time to the first treated relapse, and a significant reduction in the number of treated relapses. Patients who received Novantrone also experienced a significant reduction in the number of new MS lesions seen on Magnetic Resonance Imaging (MRI).
Novantrone works in MS patients by suppressing the activity of certain white blood cells known as T cells, B cells and macrophages which are thought to lead the attack on the myelin sheath. Current indications for Novantrone include its use, in combination with corticosteroids, to treat pain in patients with advanced hormone-refractory prostate cancer and for initial therapy of acute nonlymphocytic leukemia.
According to Craig H. Smith, MD, Director of Regional MS Center at Swedish Hospital Medical Center, "There's a fairly dramatic reduction in not only attack rate, clinical attack rate, so the attack from the standpoint of what I see clinically is reduced in patients on it. But also, the MRI changes. In patients that have MS, there are areas that we can see on MRI where the brain is inflamed."
For Debbie, Novantrone offered her more than treatment--it offered her hope.
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