CHICAGO, Jan. 31, 2024 — Despite today’s announcement from Biogen, the Alzheimer’s Association is extremely optimistic about the future of Alzheimer’s treatments; a new era that started with the Food and Drug Administration (FDA) accelerated approval of Aduhelm in 2021.
Approval of Aduhelm was a landmark event for the Alzheimer’s field and, most importantly, provided hope for the millions of people living with early Alzheimer’s, and their families. It was the first FDA-approved treatment to address one of the underlying causes of the disease, not just the symptoms. And the field has continued to advance.
- Leqembi is FDA-approved and available now, and is covered by Medicare when the prescribing physician participates in a CMS-approved registry.
- Donanemab is in review at the FDA; a decision is expected in the coming months.
- The Alzheimer’s treatment pipeline is robust, with a wide variety of treatment targets being investigated.
The Alzheimer’s Association recommends that people receiving Aduhelm through a clinical trial or by prescription, and their families, should connect with their study contact and/or their personal health care provider to talk through how these changes will impact their treatment and care.
CMS denied Medicare coverage to this treatment — approved by the FDA using the accelerated approval pathway — unless the patient was enrolled in a clinical trial. We believe this contributed to limiting the number of people living with Alzheimer’s, a fatal disease, who could get access to the approved treatment, and created significant confusion for patients and doctors.
More information about Alzheimer’s diagnosis, treatment and coverage options, and dozens of Alzheimer’s/dementia research studies near you, is available at the Alzheimer’s Association website at alz.org.