Rhone Poulenc Rorer
Approved December 1995
amyotrophic lateral sclerosis
Rilutek is the first drug shown to provide some benefit to people with amyotrophic lateral sclerosis. No treatment has previously been available for this fatal, neurodegenerative disease since it was first described 126 years ago.
In the largest ALS clinical trial ever, Rilutek was shown to extend the survival of ALS patients by three months. A total of 959 patients participated in a multicenter, double-blind, placebo-controlled phase III trial, in which survival served as the primary endpoint.
In addition to demonstrating a survival benefit, Rilutek was generally well tolerated. Side effects reported in the trial included nausea, fatigue, and elevated liver enzymes.
The outward signs of ALS are progressive weakness and deterioration of the muscles (amyotrophic), beginning in the limbs, usually on one side of the body (lateral). Inside the body, the nerves controlling motor function die off after their cell bodies become hardened and shriveled (sclerosis), leaving the patient increasingly helpless.
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