Alzheimer's drug wins FDA panel's support
By Wire services
Published September 25, 2003
BETHESDA, Md. - A Food and Drug Administration panel on Wednesday recommended approval of an Alzheimer's treatment that would be the first drug available in the United States for patients with more severe forms of the disease.
Memantine has been sold in Germany since 1980 and was approved by the European Union for moderate to severe Alzheimer's in 2002. Many desperate Americans have been importing memantine, marketed as Namenda, by mail and ordering it over the Internet in a bid to keep the disease at bay.
The FDA, which must decide by Oct. 19, generally follows its advisers' recommendations. Lawrence Olanoff of Forest Laboratories, the drug's maker, said the drug, if approved, could be on shelves by early next year.
But the FDA's advisers struggled with how much benefit memantine offers and if it could give false hope to families of the most severely ill patients.
"I believe this to be a very small effect size," cautioned the panel's chairwoman, Dr. Claudia Kawas of the University of California, Irvine. "The entire committee has certain concerns."
When it comes to benefit for the most severe Alzheimer's patients, "I'm very unimpressed," said Dr. Roger Packer, a Washington neuroscientist.
Still, the FDA panel voted unanimously that memantine offers some benefit to people with moderate to severe Alzheimer's symptoms and is safe to try.
If the FDA agrees, memantine would mark an important step in Alzheimer's therapy. None of the four drugs on the market is approved for treatment of the disease in its more severe forms. Aricept, Exelon, Reminyl and Cognex work by raising acetylcholine levels in the brain. Memantine blocks glutamate, a brain messenger chemical thought to damage or destroy nerve cells. The drug could let doctors, for the first time, prescribe drug combinations in hopes of better results.
Families out of options are eagerly awaiting memantine. Forest says it receives more than 1,000 calls a month from families desperate to buy it in this country.
"These are priceless moments regained," said Barry Cooper of Arlington, Va., who told the FDA panel his wife, Linda, talks more and regained small skills since starting memantine bought abroad.
"Every month can count," he said, urging the FDA to act quickly.
Memantine is not miraculous, even company-affiliated researchers acknowledged. But it can help stabilize patients so they maintain certain functions for a few months longer, said Dr. Pierre Tariot of the University of Rochester, who led one of the critical studies.
He said studies suggest memantine gives some patients the ability go to the toilet independently for six more months.
A six-month study of patients with moderate to severe Alzheimer's symptoms found those given memantine worsened significantly slower - by one measure, at half the pace, researchers said. In a second study, patients taking the older Alzheimer's drug Aricept found added benefit when they took memantine.
Some patients reported improvements in memory and thinking skills. For most, however, the drug simply slowed the pace of deterioration.
Forest Laboratories estimated 1-million to 2-million of the 4.5-million Americans with Alzheimer's disease would benefit.
FDA panelists could not say how much benefit patients got. More confusing, when FDA's scientists looked at just the most severely ill patients, in one study memantine seemed to have no effect and only moderately ill patients were helped.
FDA's advisers could not say how the average doctor would know who should get the pill and when the medication would be a waste of time.
- Information from the New York Times and Associated Press was used in this report.
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