Pfizer's Aricept gets Canadian OK for severe AD

US pharmaceutical giant Pfizer says that Health Canada has approved its drug Aricept (donezepil HCl tablets) for the treatment of the symptoms of severe Alzheimer's disease. Pfizer said that the decision makes its product the first to be approved for mild, moderate and severe forms of the disease.

Health Canada's decision is based on clinical data from three late-stage trials, including those from a six-month, multi-center, randomized, placebo-controlled study that enrolled 248 Swedish nursing home patients suffering from severe AD. The results of this assessment, which were published in The Lancet early last year, showed that a 10mg dose of Aricept conferred statistically-significant benefits, in terms of both the Severe Impairment Battery for cognition and the Modified AD cooperative study activities of daily living inventory, compared with placebo.

Pfizer welcomed the approval decision, noting that the drug, which is the number one AD medication worldwide, is available on prescription in 44 countries and has surpassed one billion patient days of use over the 10 years since it was first approved (Marketletters passim).