Rhone-Poulenc Rorer Inc., which last week initiated a program toprovide its Lou Gehrig's disease drug to patients on a lottery basis,has filed for approval of the small molecule compound with the FDA.
Rhone-Poulenc Rorer, of Collegeville, Pa., has said it will giveRilutek, or riluzole, free to amyotrophic lateral sclerosis (ALS)patients in the U.S. until the FDA acts on the company's new drugapplication (NDA), which was submitted Thursday. No cure oreffective treatments are marketed for the deadly neurodegenerativedisease, which affects about 35,000 Americans and usually kills itsvictims in three to five years.
In Phase III studies, Rhone-Poulenc Rorer, a subsidiary of France-based Rhone-Poulenc Group, said Rilutek prolonged ALS patients'lives up to three months, but was not effective in slowing musclefunction deterioration.
The drug is the first treatment attacking the underlying mechanism ofthe disease to be presented for FDA approval.
Cephalon Inc., of West Chester, Pa., also has reported successfulPhase III studies of its ALS drug, Myotrophin, which is arecombinant human-insulin like growth factor. Results of those trialsdemonstrated the drug slowed progression of the disease andimproved patients' conditions. Cephalon expects to file an NDA byearly 1996.
Rhone-Poulenc Rorer (NYSE:RPR) closed Thursday at $41,unchanged. Cephalon (NASDAQ:CEPH) gained $1.62 to end the dayat $18.50. _ Charles Craig
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