Drug Helps Delay Progression of Multiple Sclerosis

The first anti-cancer drug to be proven effective in treating patients with advanced or chronic multiple sclerosis (MS) was approved for this new use by the Food and Drug Administration in October. Novantrone (mitoxantrone hydrochloride), which is administered intravenously by a doctor, reduces the frequency of flare-ups and helps keep mobility in patients with secondary (chronic) progressive, progressive relapsing, or worsening relapsing-remitting MS. These are all forms of MS in which patients become significantly worse between relapses and over time. The drug is not, however, approved for treating primary progressive MS, one form in which the patient's neurologic condition deteriorates over time without specific relapses.

MS is a highly debilitating autoimmune disease that attacks the nervous system and can cause weakness, impaired vision, loss of balance, and poor muscle coordination. The disease can have different patterns, sometimes leaving patients relatively well after episodes of acute worsening, and other times leading to progressive disability that persists after episodes of worsening. In the worst cases, MS can lead to paralysis. According to the Multiple Sclerosis Foundation, more than 300,000 Americans are diagnosed with MS today.

FDA cautions that some patients treated with Novantrone may develop serious heart problems. The risk of congestive heart failure increases with the cumulative dose, and patients with MS should ordinarily not receive more than eight to 12 doses administered over two to three years. FDA advises having the heart and blood tested regularly to help avoid serious side effects. Less severe side effects include nausea, hair thinning, loss of menstrual periods, bladder infections, and mouth sores.

Novantrone is manufactured for Immunex Corporation, of Seattle, by Lederle Labs.