RILUTEKŽ (riluzole) APPROVED BY U.S. FOOD AND DRUG ADMINISTRATION
FOR TREATMENT OF LOU GEHRIG’S DISEASE
First Drug to Effectively Treat Disease Since it was First Described in
1869
Collegeville, PA, USA, December 12, 1995 — Rhône-Poulenc Rorer Inc.
(NYSE: RPR) announced today that it has received clearance from the U.S.
Food and Drug Administration (FDA) to market RilutekŽ (riluzole), the
first effective drug for the treatment of amyotrophic lateral sclerosis
(ALS or Lou Gehrig’s disease). No treatment was previously available for
this fatal, neurodegenerative disease since it was first described 126
years ago.
Rilutek is the first drug shown to extend survival in people with ALS.
The New Drug Application (NDA) received approval from the U.S. FDA less
than six months after RPR submitted it on June 29, 1995.
Rilutek is the first drug to demonstrate efficacy in the treatment of
ALS,” said Gary T. Shearman, Ph.D., Senior Vice President, Drug
Development, RPR. “It represents a critical first step and important
therapeutic gain in ALS treatment. Our number one goal is to make the
drug available to ALS patients as quickly as possible.”
Rilutek will be available by prescription in six weeks as a 50 mg tablet
to be administered twice daily. An official launch news conference will
be held on January 10, 1996, to discuss drug availability and patient
support services (a separate announcement will identify the exact time and
location). A toll-free telephone number will be available for people who
cannot attend the conference.
People who have questions about Rilutek before January 10th can
call 1-800-RX-TRIAL (1-800-798-7425) for more information.
Clinical Trial Results
In the largest ALS clinical trial ever, Rilutek was shown to
extend the survival of ALS patients. A total of 959 patients
participated in a multi-center, double-blind, placebo-controlled Phase
III trial, in which survival served as the primary endpoint.
In addition to demonstrating a survival benefit, Rilutek was generally
well-tolerated. Side effects reported in the trial included nausea,
asthenia (fatigue) and elevated liver enzymes.
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. The participating centers were
Baylor College of Medicine, Veterans Affairs Medical Center (Houston);
Johns Hopkins University (Baltimore); Northwestern University (Chicago);
California Pacific Medical Center (San Francisco); and Tufts-New England
Medical Center (Boston).
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.
The outward signs of ALS are progressive weakness and deterioration of the
muscles (amyotrophic), beginning in limbs, usually on one side of the body
(lateral). Inside the body, the nerves controlling motor function die off
after their cell bodies become hardened and shriveled (sclerosis), leaving
the patient increasingly helpless.
The FDA allowed an Early Access Program (EAP) treatment protocol
to proceed on June 20, 1995. The EAP was established by RPR to allow a
limited number of people with ALS to receive Rilutek free-of-charge
pending FDA approval and commercial availability. A total of 3,000
patients were selected to participate in
the program.
Rhône-Poulenc Rorer is a global pharmaceutical company
dedicated to improving human health.
Editor’s Note:
1) The January 10, 1996 news conference will include ALS medical
experts, patients, patient advocacy groups, and RPR representatives.
