NEWS

12/12/1995



<TITLE> FDA APPROVES FIRST DRUG FOR LOU GEHRIG'S DISEASE </TITLE>

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P95-11                             Food and Drug Administration

FOR IMMEDIATE RELEASE              Susan Cruzan (301) 443-3285

December 12, 1995                  (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    

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                                      Page 2, P95-11, ALS

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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