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Date: Tuesday, December 12, 1995
FOR IMMEDIATE RELEASE
Contact: Susan Cruzan, FDA (301) 443-3285; Home: (301)834-7332

FDA Approves First Drug for Lou Gehrig's Disease

The Food and Drug Administration today announced the approval of riluzole, the first drug that has been shown to prolong the survival of patients with amyotrophic lateral sclerosis (ALS), also known as Lou Gehrig's disease.

ALS, which results in progressive muscular weakness and paralysis, has been without cure since it was first identified in 1869. FDA carried out the review of riluzole in five-and-a-half months.

Commenting on the approval, Secretary of Health and Human Services Donna E. Shalala noted that when tested in two placebo-controlled studies on more than 1,000 patients, riluzole prolonged survival on average by about three months.

"This is a modest effect, but before riluzole there was no therapy for ALS at all," the Secretary said. "Today's approval is an important milestone in the decades-long search for treatment for this devastating disease."

FDA Commissioner David A. Kessler, M.D., pointed out that before today's approval, riluzole had been made available to more than 3,000 patients -- about one-tenth of the 30,000 Americans with ALS -- under an early access program granted by FDA and administered by the National Organization for Rare Disorders.

"This is the first drug we have ever had that seems to make a difference in the course of ALS -- a dreadful disease," Kessler said. "We hope this is just a first step."

ALS is a progressive disease that affects nerve cells in the brain and spinal cord and is usually fatal within five years after diagnosis. Adverse effects of riluzole observed in clinical tests include weakness, nausea, vomiting and elevated liver enzymes.

FDA's Peripheral and Central Nervous System Drugs Advisory Committee reviewed the data from trials on riluzole on September 18, and recommended its approval for treatment of ALS.

Riluzole is manufactured by Rhone-Poulenc Rorer Inc. of Collegeville, Pa., and is distributed under the trade name Rilutek.

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