FDA OKs New Alzheimer's Option

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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.