Novartis gains US approval for Exelon

24 April 2000

Novartis has received US Food and Drug Administration approval tomarket its Alzheimer's disease drug Exelon (rivastigmine). This will be the third Alzheimer's medication to hit the US market after Eisai/ Pfizer's Aricept (donepezil) and Warner-Lambert's Cognex (tacrine), and will be made available in May at a wholesale price of $130 per month.

Novartis' compound has been cleared for marketing in more than 65 countries, including the European Union member states, Australia and Canada.

Exelon is an acetylcholinesterase inhibitor which is believed to have a similar efficacy to the two already-available compounds. The approval was based on data from more than 3,900 patients worldwide - the largest Phase III program ever conducted with a drug for dementia of the Alzheimer's type, the company notes. Patients showed benefits on nearly all activities of daily living compared to placebo, as well as improved behavioral symptoms. Furthermore, Novartis claims that: "in clinical studies published to date, Exelon shows the greatest benefit in cognition compared to placebo."

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