Alzheimer's Association Encouraged by U.S. FDA Advisory Committee Recommendation of Approval for Memantine

Alzheimer's Association
Wednesday, 24 September 2003

The Alzheimer's Association is encouraged by the recommendations of an advisory committee to the U.S. Food and Drug Administration (FDA) to approve memantine as a potential treatment for moderate to severe Alzheimer's disease (AD).

"Today's action could provide additional and alternative 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. "Since its inception in 1980 when no treatments for AD were available, the Alzheimer's Association has been a strong advocate for the development of a broad spectrum of interventions for all stages of the disease. The Association, through its scientific program, has been a champion of drug development using different approaches and exploiting a variety of different mechanisms of action."

"For patients, families and physicians, the prospect of another treatment raises the possibility that the drug can be used either alone or in combination with other approved treatments. The eventual goal is to create 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," Thies said.

The FDA Advisory Committee's Action

On Wednesday, September 24, the FDA's Peripheral and Central Nervous System Drugs Advisory Committee recommended approval of memantine for treatment of moderate to severe Alzheimer's disease.

The FDA is under no legal obligation to accept guidance from advisory committees, though the agency often follows their recommendations. An FDA advisory committee provides independent, expert scientific and medical advice to the FDA on the safety, effectiveness, and appropriate use of products under its jurisdiction.

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 AD. 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 – if it as approved by the FDA – either as stand-alone therapy or in combination with cholinesterase inhibitors.

The four currently approved drugs for AD all are indicated for use in patients with mild to moderate disease. If approved, memantine would be the first drug indicated for moderate to severe AD.

The Challenges of Late Stage Alzheimer's

Having a loved one in the later stages of AD can be an extremely difficult time for caregivers and family members. People with advanced AD often have very little ability to live and function independently. They often need full or partial assistance with most or all of the activities of daily living, such as bathing, dressing, eating, and using the bathroom. Plus – and this is perhaps the most painful for family – their personality is slowly slipping away.

FDA Committee Action Points to Need for More Federal Research Funding

Thies pointed out that current drug treatments for AD help ease some of the symptoms of the disease, and then generally only for a short period of some months. Approved treatments do not yet address the underlying cause of the disease.

"It must be recognized that 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 AD to actually slow or stop its inexorable progression and eventually prevent its relentless destruction of brain cells," Thies said.

"The potential approval of another symptomatic treatment further underscores the need to step up the federal commitment to research into the cause of AD, 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.

For more information, or to contact Alzheimer's Association, see their website at: www.alz.org