News | October 13, 2000

FDA approves Novantrone for secondary progressive MS

First therapy approved for this indication

The U.S. Food and Drug Administration (FDA) has approved Novantrone (mitoxantrone for injection concentrate) for secondary progressive multiple sclerosis (MS). Novantrone, marketed by Immunex Corp. (Seattle), is the first therapy approved for this indication. With the approval, the drug is now indicated for reducing neurologic disability and/or the frequency of clinical relapses in patients with secondary progressive, progressive relapsing, or worsening relapsing-remitting MS.

The approval is based on the results of a Phase III clinical trial in which Novantrone, at a dose of 12 mg/m2, was administered by short IV infusion once every three months. The study 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. In addition, there was a significant reduction in the mean number of treated relapses, and also a significant reduction in the number of Novantrone patients who had new MS lesions seen on magnetic resonance imaging (MRI).

MS is a chronic, often debilitating disease of the central nervous system that affects some 350,000 people in the United States. MS symptoms result when the myelin sheath, the fatty substance that insulates the nerve fibers of the brain and spinal cord, breaks down occurs, patches of scar tissue, or "sclerosis," that interfere with the nerve's ability to transport messages from the brain. Disease symptoms include everything from numbness in the limbs to complete paralysis. Approximately half the U.S. patients with MS will eventually develop active progressive forms of the disease—secondary progressive, progressive remitting, and worsening relapsing-remitting MS.

Novantrone acts by suppressing the activity of 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.

Immunex Corp. is a biopharmaceutical company dedicated to improving lives through immune system science innovations.

For more information, contact Tim Warner of Immunex at 206-470-4193.

Edited by Jim Pomager
Assistant Editor, Pharmaceutical Online