COGNEX APPROVED FOR ALZHEIMER'S IN USA

19 September 1993

The US Food and Drug Administration has approved Warner-Lambert's anti-Alzheimer's drug Cognex (tacrine), which was developed by the company's Parke-Davis division. The clearance came only a few months after an approval recommendation by the FDA's Peripheral and Central Nervous System Drugs Advisory Committee.

The approval was based on two studies carried out since the drug was originally turned down in 1991. The two placebo-controlled studies, of 12 and 30 weeks' duration, showed that there was a "significant difference in objective and subjective outcomes," in patients with mild-to-moderate disease, said the company.

The subjective evaluation consisted of a measure of the global change patients underwent in the CIBI (clinician interview-based impression) scale. This evaluation measured physicians' global impression in changes in memory, orientation, language, reasoning, concentration, appearance and behaviour. The objective scale, the cognitive sub-scale of the Alzheimer's Disease Assessment Scale (ADAS-cog), measured memory, reasoning, attention, language and the ability to perform simple tasks.

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