First Approved Therapy For ALS From R-PR

Sufferers of the devastating neurodegenerative disease amyotrophic lateral sclerosis now have an approved drug to treat their condition, the first one since the syndrome was described in 1869. Rhone-Poulenc Rorer's Rilutek (riluzole) has now been approved in the USA, less than six months after the application dossier was filed.

Rilutek is the first drug which has been shown to actually improve survival in ALS patients. In the absence of treatment, patients developing the disorder undergo a progressive and crippling weakness of the muscles, usually beginning on one side of the body, which ultimately results in paralysis and death (by respiratory failure) within three to five years. Rilutek has a modest but significant effect on survival - increasing it by around three months - according to the results of Phase III trials.

The Phase III data was presented earlier this year at the 47th annual meeting of the American Academy of Neurology in Seattle, USA. The 950-patient study compared riluzole at one of three doses (50mg, 100mg or 200mg/day in three doses) to placebo and was conducted over a 14- to 18-month period. The evaluation revealed a 12.7% increase in the number of patients alive after 18 months who received riluzole at the 100mg/day dose compared to placebo. 56.8% of those on 100mg riluzole were alive after this period compared to 50.4% of those on placebo. Riluzole was unable to demonstrate a statistically significant effect on the rate of muscle function deterioration for the overall ALS population.