In addition to demonstrating a survival benefit, Rilutek was generally well-tolerated. The Phase III trial was conducted at 31 sites in Europe and North America. In the United States, all centers were certified and funded by the Muscular Dystrophy Association. ALS is a fatal, neuromuscular disease affecting approximately 25,000 to 30,000 people in the United States and 70,000 people worldwide. It attacks nerve cells in the brain and spinal cord, resulting in muscle paralysis and respiratory failure.
Patients generally survive three to five years after diagnosis.
A total of 3,000 patients were selected to participate in the program. Rhone-Poulenc Rorer is a global pharmaceutical company dedicated to improving human health. ALS, which results in progressive muscular weakness and paralysis, has been without cure since it was first identified in 1869. 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. Today's approval is an important milestone in the decades-long search for treatment for this devastating disease.