FDA approved Warner-Lambert's Cognex (tacrine) for thetreatment of mild-to-moderate Alzheimer's disease onThursday. It is the first Alzheimer's treatment to be approvedby the agency.

Approval is based on two placebo-controlled studies of 12 and30 weeks duration that showed that Cognex improved cognitiveperformance and the ability to perform many activities of dailyliving. Warner- Lambert said "there is no evidence that Cognexalters the course of the underlying dementing process." Cognexis an acetylcholine inhibitor that is believed to improvecognitive function by preventing the destruction ofacetylcholine, a neurotransmitter that carries messages to thebrain.

Cognex was recommended for approval by FDA's Peripheraland Central Nervous System Drugs Advisory Committee inMarch. The committee had previously declined to recommendapproval when it reviewed the drug in March 1991, and at asecond meeting in July 1991, requested that Warner-Lambertconduct an additional study using a higher dose of Cognex overa longer period of time. The data presented to the committee atthat time involved dosages of 40 milligrams and 80 milligrams,which showed slight clinical effectiveness. The maximumapproved dosage is 160 milligrams per day. Patients are to betitrated from 40 milligrams.

Warner-Lambert, of Morris Plains, N.J., said that in clinicaltrials the most frequent side effect with Cognex was elevationof liver enzymes, with 29 percent of patients experiencingsignificant elevations. "In all cases, liver enzyme levels havereturned to normal when Cognex therapy was reduced ordiscontinued," the company stated.

Warner-Lambert (NYSE: WLA) has Cognex applications pendingin France, the United Kingdom and Canada. Several othercompanies have Alzheimer's drugs in the pipeline. Hoechst-Roussel has filed a new drug application (NDA) for Mentane(velnacrine) and Sigma Tau, Du Pont Merck, Hoffmann-LaRoche, Miles, Glaxo and Forest Laboratories have drugs in PhaseIII trials.

-- Brenda Sandburg News Editor

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