FDA Grants Accelerated Approval of New Alzheimer’s Treatment; Association Pushes for Access

President & CEO of the Alzheimer’s Association, Joanne Pike, DrPH sent the following message Friday: The Food and Drug Administration (FDA) has granted accelerated approval to lecanemab, brand name Leqembi, for patients confirmed to be in early stage Alzheimer’s disease. As we shared with you previously, rigorous clinical trials show this drug can meaningfully change the course of the disease.

This treatment slows disease progression and offers the promise of more time — more time to participate in their daily lives, live independently, or attend a graduation, the birth of a grandchild, or other experiences that mean the most to the person living with the disease.

And many additional treatments are in the pipeline that can continue to move us forward from this important announcement. That’s important because Leqembi will only help those in the early stages of the disease; we have much more work to do to develop treatments when the disease has progressed. This is why we have worked so tirelessly to advocate for access to effective treatments like Lequembi, and we should all celebrate this major milestone.

And yet, our celebration is dampened by a painful reality. Medicare has already put in place unprecedented barriers to access that have never existed for FDA-approved drugs for any other disease. The result: The only people on Medicare who will have access to this new drug will be those who can afford to pay for it out of pocket. This is unacceptable.

The Alzheimer’s Association and the Alzheimer’s Impact Movement have filed a formal request for Medicare to provide full, unrestricted coverage for FDA-approved Alzheimer’s treatments. With your help, we have elevated the vital voices of people living with dementia and will continue to do so in the months ahead.

Individuals should talk with their doctors to discuss treatment options that may be right for them, including weighing the benefits and risks of all approved therapies.

We have never been more hopeful for the course of this disease, and we hope you share our excitement on behalf of those who may benefit from Leqembi. We will not rest until those with Alzheimer’s can count on the same Medicare coverage as do those with other diseases. As this process continues, we will keep you apprised.


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