WARNER-LAMBERT ISSUES STATEMENT FOLLOWING FDA AUTHORIZATION OF EXPANDED ACCESS FOR ALZHEIMER'S DRUG COGNEX
WARNER-LAMBERT ISSUES STATEMENT FOLLOWING FDA AUTHORIZATION
OF EXPANDED ACCESS FOR ALZHEIMER'S DRUG COGNEX
MORRIS PLAINS, N.J., Dec. 3 /PRNewswire/ -- Warner-Lambert Company (NYSE: WLA) today issued the following statement after the U.S. Food and Drug Administration authorized wider use of the company's Alzheimer's drug Cognex (tacrine or THA):
We're pleased that the FDA has acted swiftly on the company's proposal to allow wider use of Cognex for patients with Alzheimer's disease.
Approval of the treatment IND program is an important step in the regulatory process. The program will make the drug available to many thousands of patients, with the objective of treating as many as 3,000 patients with Cognex at higher doses. Besides making the drug available to a broader population of Alzheimer's patients, the Treatment IND will allow the company to collect additional safety data.
We will continue to work closely with the FDA to finalize the protocol under which the drug will become available and cannot foresee any circumstances that would preclude the successful initiation of the program in February.
As previously announced, the company also recently began enrolling patients in a 500-patient study that will evaluate the effectiveness of Cognex at higher doses over a longer period of time. The trial is a double blind, placebo-controlled, parallel group design at doses as high as 160 mg. per day. The study, involving 33 test sites nationwide, should be completed by early 1993.
Warner-Lambert is a worldwide company devoted to developing, manufacturing and marketing quality health care and consumer products. It employs approximately 35,000.
/CONTACT: Peter Wolf, 201-540-6696, or Sandy Bell, 201-540-2145, both of Warner-Lambert/
(WLA) CO: Warner-Lambert Company ST: New Jersey IN: MTC SU: SH -- NY033 -- 8704 12/03/91 11:00 EST