Alzheimer's Association Encouraged by FDA Approval of Memantine 10/17/2003
From: Niles Frantz, 312-335-5777 or 312-286-0295 (cell), Alzheimer's Association media line, 312-335-4078 CHICAGO, Oct. 17 -- The Alzheimer's Association is encouraged by today's U.S. Food and Drug Administration (FDA) approval of memantine to treat moderate to severe Alzheimer's disease. "Today's FDA action provides additional strategies to intervene with the devastating effects of Alzheimer's disease," said William Thies, Ph.D., vice president, Medical and Scientific Affairs for the Association. "In particular, this is the first treatment approved for those with more severe Alzheimer's disease." The Alzheimer's Association is a strong advocate for the development of a broad spectrum of interventions for all stages of the disease. "The Alzheimer's Association, through its research grantmaking program, has been a champion of drug development using different approaches and exploiting a variety of different mechanisms of action," Thies said. "For patients, families and physicians, having a new approved treatment with a novel mechanism of action -- as is the case with memantine -- raises the possibility that the drug can be used either alone or in combination with other approved treatments. Our goal is to have multiple treatment options so that physicians can find a therapy that works safely and effectively for every person with the disease," Thies said. Newly published research suggests that 4.5 million Americans now have Alzheimer's disease. As the baby boom generation ages, the estimated Alzheimer prevalence is 11.3 million to 16 million by 2050. "The discovery of effective new interventions is urgently needed to stem the tide of the pending worldwide epidemic of Alzheimer's disease, its devastation of individuals and families, and the potential bankrupting of the American healthcare system due to its costs," said Sheldon Goldberg, president and CEO of the Alzheimer's Association. The FDA's Action On Friday, October 17, the FDA approved memantine (brand name, Namenda) for treatment of moderate to severe Alzheimer's disease. Memantine is manufactured and marketed in the United States by Forest Laboratories. FDA Action Points to Need for More Federal Research Funding Thies pointed out that current drug treatments for Alzheimer's, including memantine, help ease some of the symptoms of the disease. Approved treatments do not yet address the underlying cause of the disease. "America's 4.5 million people with Alzheimer's disease, their caregivers and family members desperately need therapies that go beyond treating only the symptoms of Alzheimer's to actually slow or stop its progression and prevent its relentless destruction of brain cells," Thies said. "The approval of another symptomatic treatment further underscores the need to increase the federal commitment to research into the cause of Alzheimer's disease, so that we can rationally develop strategies for preventing and even curing this disease," Thies added. The Alzheimer's Association is working with Congressional leaders to increase federal funding for Alzheimer research from the estimated $640 million the National Institutes of Health will spend in 2003 to $1 billion annually. About Memantine Memantine appears to regulate the activity of glutamate, one of the brain's specialized messenger chemicals. At normal concentrations, glutamate plays an essential role in learning and memory. Imbalances in glutamate levels are thought to be one factor that may contribute to Alzheimer-related memory problems and to damage or destroy nerve cells. Because these interactions are out of balance in Alzheimer's disease and some related disorders, the drug may help maintain normal processes that promote cell health. Memantine's action in the glutamate system differs from the activity of the four cholinesterase inhibitors that are currently approved in the U.S. for treatment of Alzheimer's disease. Cholinesterase inhibitors temporarily boost levels of acetylcholine, another messenger chemical that becomes deficient in the Alzheimer brain. These differing modes of action raise the possibility that individuals may be able to take memantine either as stand-alone therapy or in combination with cholinesterase inhibitors. The four currently approved drugs for Alzheimer's disease all are indicated for use in patients with mild to moderate disease. Memantine is the first drug indicated for moderate to severe Alzheimer's disease. The Alzheimer's Association The Alzheimer's Association is the world leader in Alzheimer research and support. Having awarded more than $150 million to nearly 1,300 projects, the Alzheimer's Association is the largest private funder of AD research in the U.S. The association's vision is a world without Alzheimer's disease. For more information about Alzheimer's disease, research and treatments, please visit http://www.alz.org or call 800-272-3900. |