Alzheimer’s drug approved

Alzheimers drug approved

Drug dosage was increased despite the side effects

THE NEW YORK TIMES

March 23, 2012

Four months before a best-selling Alzheimers drug was set to lose its patent protection, its makers received approval for a higher dosage that extended their exclusive right to sell the drug. But the higher dosage caused potentially dangerous side effects and worked only slightly better than the existing drugs, according to an article published Thursday in the British Medical Journal.

The drug, Aricept 23, was approved in July 2010 against the advice of reviewers at the Food and Drug Administration.

They noted that the clinical trial had failed to show that the higher dosage 23 milligrams versus the previous dosages of five and 10 milligrams met its goals of improving both cognitive and overall functioning in people with moderate to severe Alzheimers disease.

The single clinical trial of 1,400 patients also found that the larger dosage led to substantially more nausea and vomiting, potentially dangerous side effects for elderly patients. The drug was developed by the Japanese company Eisai but is marketed in the United States with Pfizer.

It doesnt really have much benefit but does substantially more harm, said Dr. Steven Woloshin, one of the co-authors of the journal article and a professor of medicine at the Dartmouth Institute for Health Policy and Clinical Practice.

Aricept generated more than $2 billion in annual sales since its first approval in 1996, according to the journal article, but it was set to lose its patent protection in November 2010, opening the door to cheaper generic versions.

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Alzheimer’s drug approved