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Drug for Advanced Alzheimer's Is OKd

The FDA says Namenda slows patients' decline in the late stages of the brain disease.

October 18, 2003|From Reuters

WASHINGTON — U.S. health officials on Friday approved the first medicine for treating the late stages of Alzheimer's, the degenerative brain disease that afflicts an estimated 4 million Americans.

Namenda, made by Forest Laboratories Inc., slowed the decline in awareness, reasoning and daily function experienced by patients with moderate to severe Alzheimer's who were treated in clinical trials, the Food and Drug Administration said.

The disease causes a gradual loss of brain cells, resulting in memory loss and dementia, and can eventually lead to death.

In the studies, most patients' mental and functional ability did deteriorate. But on average those given Namenda were better able to perform such tasks as feeding themselves or dialing a phone than those given a placebo, the FDA said.

Forest said Namenda will address an important medical need because the moderate to severe stages of Alzheimer's can last for years.

"It certainly provides a modest, but we think meaningful, benefit," said Charles Triano, Forest's vice president for investor relations.

The drug should be available in January, Triano said.

The FDA action follows last month's unanimous recommendation for approval from an FDA advisory panel. Members of the panel agreed that the drug was safe and effective but stressed that benefits appeared limited.

Namenda, known generically as memantine, is the first of a new type of medicines for treating Alzheimer's disease.

Researchers believe Namenda calms overstimulated nerve cells in the brain by blocking activity of the chemical glutamate.

The four other approved Alzheimer's drugs are cleared only for treating mild to moderate forms of the illness, and they also offer modest benefits.

Those drugs, which include Aricept from Pfizer Inc. and Eisai Co., work by helping to make the chemical acetylcholine more available in the brain. Acetylcholine plays an important role in learning and memory.

In clinical trials, Namenda was used alone or with another Alzheimer's treatment. Side effects were minor and included dizziness, headache and constipation, the FDA said.

Alzheimer's patients, families and caregivers had been waiting for regulatory approval of Namenda. At last month's advisory panel meeting, some said they had sought out supplies of the drug overseas.

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