FDA grants approval of Alzheimer’s drug

The following message is from Joanne Pike, President and CEO of the Alzheimer’s Association.

Today, we are living history: the U.S. Food and Drug Administration (FDA) granted traditional approval of lecanemab, sold under the brand name Leqembi, for the treatment of early-stage Alzheimer’s disease. This is the first traditional approval granted for an Alzheimer’s treatment that changes the underlying course of the disease. Learn more here.

In addition, the Centers for Medicare & Medicaid Services (CMS) announced it will cover the treatment through Medicare. Read our statement here.

The Alzheimer’s Association has long been the leading voice on behalf of people living with this fatal disease. They deserve the opportunity to discuss and choose, with their doctors and family, whether an approved treatment is right for them with as few barriers as possible.

We owe a debt of thanks to all who worked to make this happen bipartisan members of Congress, state attorneys general, clinicians, and, most importantly, the thousands of our volunteers from communities all across the country.

While this is a tremendous step forward, the Alzheimer’s Association’s work is far from done. We won’t rest until everyone living with Alzheimer’s — at any stage — can get the treatment, care and support they need and deserve.

The next few weeks and months are critically important. We will work closely with CMS, other payers, the physician community, our health systems and other community partners to work toward a smooth rollout for patients who can benefit.

Thank you for all you do to move our mission forward. You can always find additional information at alz.org or at our 24/7 Helpline (800.272.3900). Published July 7,2023