FDA OKs New Alzheimer’s Option
WASHINGTON (AP) _ A third medication to treat Alzheimer’s disease, Novartis Pharmaceuticals’ Exelon, has received approval by the Food and Drug Administration.
Four million Americans suffer from Alzheimer’s, which has no known cause or cure. It afflicts mainly the elderly, robbing them of their memories and ability to care for themselves and eventually killing them.
Exelon, whose approval was announced Friday, works in the brain the same way as the other two Alzheimer’s drugs, Aricept and Cognex. They inhibit the breakdown of acetylcholine, a brain chemical vital for nerve cells to communicate with each other. The longer acetylcholine remains in the brain, the longer those cells can call up memories.
The drugs offer modest relief for mild to moderate Alzheimer’s symptoms. While the products have not been compared directly, Exelon’s effectiveness is believed to be ``pretty much in the same league″ as Aricept and Cognex, said FDA official Dr. Russell Katz.
After 26 weeks of therapy, 81 percent of Exelon patients had stable or slightly better symptoms than patients given a dummy pill, Novartis said.
But Katz noted that Exelon’s label bears a strong warning about a significant risk: It can cause nausea and vomiting severe enough that patients lose weight. In clinical trials, 26 percent of women and 18 percent of men who took high-dose Exelon lost at least 7 percent of their initial body weight.
The nausea and weight loss did end once affected patients stopped the drug. Katz noted that Alzheimer’s patients need options. ``We just don’t know who’s going to respond to which drug″ until they try one, he said.
Exelon, known chemically as rivastigmine, will be in pharmacies by the end of May, with a wholesale price of $130 for a month’s supply, Novartis said.