FDA Approves New Drug to Treat Alzheimer's Disease

Alzheimer's Association
Wednesday, 28 February 2001

Today, the Food and Drug Administration (FDA) approved a new drug, galantamine hydrobromide (Reminyl®), for treatment of Alzheimer's disease. Alzheimer's is a devastating disease that affects more than four million Americans, and that number could increase to more than 14 million by the time the "Baby Boomer" generation reaches the age of highest risk, according to the Alzheimer's Association.

"Just a few years ago, people with Alzheimer's disease and their families had very few options. Today, we look to the future optimistically, as research progresses and more treatment options become available," says Bill Thies, Ph.D., Alzheimer's Association vice president, medical and scientific affairs. "Each of the approved drugs for Alzheimer's disease may have different side effects on individual people taking the medication. Having more approved drugs offers doctors, people with the disease and their families a greater opportunity to find one that will have some benefit with the fewest unwanted effects."

The FDA approved galantamine hydrobromide as a treatment for symptomatic relief for mild to moderate Alzheimer's disease. Data from four placebo-controlled, double-blind clinical trials involving more than 2,650 patients show that galantamine hydrobromide can have a beneficial effect on patients' daily function and ability to think.

In the approval process, the data supporting the use of the drug has been judged adequate by the FDA. The drug is expected to be available by prescription in May 2001.

Currently tacrine (Cognex®), donepezil (Aricept®) and rivastigmine (Exelon®) are the only other drugs that have been approved by the FDA for treatment of Alzheimer's disease; however, none of these drugs will cure the disease.

According to Thies, individuals with Alzheimer's disease and their families should discuss the potential benefits, risks and costs of galantamine hydrobromide with their physicians before deciding whether to try it. The Alzheimer's Association does not endorse products.

The Alzheimer's Association is calling on Congress and President Bush to make conquering Alzheimer's disease a key federal health priority and is urging lawmakers to increase Alzheimer's research funding at the National Institutes of Health to $1 billion as soon as possible.

"The investment in Alzheimer research that Congress has made over the past decade is now paying off in rapid discoveries and in the development of new drug treatments," says Thies. "But even with these advances, we are still not able to prevent Alzheimer's. We need to increase the investment in research in both the private and public sectors so that we can develop more treatments and find a prevention or cure for Alzheimer's."

The Association also notes that the approval of a new drug treatment for Alzheimer's underscores the importance of Congressional action on a Medicare prescription drug benefit to make sure that beneficiaries who have Alzheimer's can obtain new therapies.

The Alzheimer's Association is the premier source of information and support for the four million Americans with Alzheimer's disease. Through its national network of chapters, it offers a broad range of programs and services for people with the disease, their families, and caregivers and represents their interests on Alzheimer-related issues before federal, state, and local government and with health and long-term care providers. The largest private funder of Alzheimer research, the Association has committed more than $100 million toward research into the causes, treatment, prevention, and cure of Alzheimer's.

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