I think that it may get approved because it falls under the Orphan Drug program of the FDA. At any rate, there is another treatment for ALS: pslgroup.com
Study Confirms That Rilutekr Tablets Extend Survival in Patients with ALS
LONDON, May 23, 1996 -- The results of a Phase III study published in the Saturday, May 25 issue of The Lancet conclude that Rilutek(R) (riluzole) "is an effective drug with an acceptable safety profile and represents a first step in the development of treatments for ALS."
Rilutek is the first treatment to demonstrate an increase in the survival of patients with amyotrophic lateral sclerosis (ALS), also known as motor neuron disease (MND) and Maladie de Charcot in Europe and Lou Gehrig's disease in the United States.
Rilutek is the only treatment shown to be effective in this fatal neurodegenerative disease, characterized by a progressive loss of motor neurons, since it was first described by French neurologist, Jean-Martin Charcot, in 1869.
"This study confirmed that riluzole extends survival in people with ALS," said Vincent Meininger, Professor of Neurology at the Hopital de la Pitie Salpetriere in Paris on behalf of the multi-center S/Riluzole Study Group Steering Committee, which also included Drs. Gilbert Bensimon and Lucette Lacomblez, also of the Hopital de la Pitie Salpetriere and Nigel Leigh, Professor of Neurology at London's Institute of Psychiatry. "Patients who took the 100 milligram (mg) dose of Rilutek every day had a significantly greater chance of being alive more than a year later than those who took a placebo," they said.
In December, 1995, the U.S. Food and Drug Administration cleared Rilutek for use in the treatment of ALS in less than six months. In Europe, a European Commission marketing authorization for Rilutek is currently being reviewed by the European Medicines Evaluation Agency (EMEA). ... |
