Novantrone Helps Worsening MS
Drug Already Available in U.S.
Dec. 27, 2002 -- Novantrone slows worsening multiple sclerosis (MS), a European study shows. Based largely on these results, the drug already has U.S. FDA approval.
Novantrone apparently inhibits the nerve-destroying immune responses at the heart of MS. It's the only drug now approved for treatment of worsening relapsing-remitting, progressive relapsing, and secondary progressive MS. The FDA approved the cancer drug for treatment in MS patients in 2000.
"We believe [Novantrone] provides a new therapeutic option," write study leader Hans-Peter Hartung, MD, Heinrich-Heine University, Düsseldorf, Germany, and colleagues.
Hartung's team enrolled 188 patients with worsening MS. A third got a placebo, another third got a low dose of Novantrone, and the final third got a higher dose of the drug. Those who received the higher dose (the FDA-approved 12 mg per square meter of body surface once every three months for 24 months) did best. On an index of five measures of MS disease -- disability status, ability to walk, number of treated relapses, time to first treated relapse, and change in neurological status -- they did 70% better than placebo-treated patients.
The drug was well tolerated. The most serious side effect of Novantrone treatment can be congestive heart failure. This is seen in up to 6% leukemia patients who, over time, accumulate a total dose of up to 140 mg per square meter of body surface. In the current study of MS patients, there were no serious heart problems. However, a few patients with previous heart problems had worsening of heart function.
The study was sponsored by Wyeth-Lederle, Novantrone's manufacturer.
Hartung and colleagues plan further studies to find out which MS patients are most likely to respond to treatment and how best to use Novantrone. They're also looking carefully for long-term side effects.