R-PR Receives EU Approval For Rilutek

Rhone-Poulenc Rorer received European Commission marketing authorization for Rilutek (riluzole), its amyotrophic lateral sclerosis treatment, in all 15 of the European Union member countries on June 11.

ALS is characterized by a progressive loss of motor neurons that renders the patient paralysed, with a common life expectancy of three to five years. Although the exact etiology of ALS has yet to be determined, it is thought that due to reuptake dysfunction, the neurotransmitter glutamate rises to abnormal levels at nerve synapses, producing an excitatory response that becomes toxic to the nerves, and this, in addition to the production of free radicals caused by a mutation in the CuZn-SOD1 gene, accelerates motor neuronal death in the spinal cord and brain.

Rilutek offers neuroprotective activity by inhibiting this glutamate release, thus reducing its toxic effects. A Phase III clinical trial, the largest ever undertaken in ALS with 959 participants (The Lancet, May 25), shows 100mg of Rilutek daily to be the most effective dose in both bulbar-onset and limb-onset ALS patients, increasing their survival rate by 35% after 18 months, compared to the placebo group. According to Vincent Meininger, neurologist at the Hopital de le Salpetriere, Paris, the therapeutic differences between Rilutek and placebo diminish in the later stages of the disease due to the reduced numbers of motor neurons, therefore it is expected that the earlier the diagnosis and treatment of ALS with Rilutek, the more successful the outcome. It is also well- tolerated; side effects include fatigue, nausea, elevated liver enzymes and asthenia. The results of this study confirmed those of the Phase II/III trial published in the March 4, 1994, issue of The New England Journal of Medicine.