Sue Peschin, MHS, President & CEO of the Alliance for Aging Research, released the following statement in response to the FDA’s decision to approve lecanemab for the treatment of mild cognitive impairment (MCI) and early dementia caused by Alzheimer’s disease:
The Alliance for Aging Research today celebrates the Food and Drug Administration’s (FDA) approval of a promising therapeutic that has illustrated the ability to help slow the progression of Alzheimer’s disease (AD). The approval for lecanemab, a new treatment for people living with mild cognitive impairment and early dementia due to AD – an irreversible, degenerative, and fatal brain disease – builds on the promising data published in the New England Journal of Medicine and validated by the views of over 140 physicians who recently sent a letter to the FDA supporting the approval.
We commend the FDA’s deliberative review under its congressionally authorized Accelerated Approval Program (AAP), and today’s announcement affirms that the program is being applied as intended. Under the accelerated route, a drug can win earlier approval if it shows an effect on a “surrogate endpoint”—in this case, amyloid plaque formation in the brain—that is reasonably likely to predict a clinical benefit to patients. The use of the AAP has been an important regulatory mechanism for the FDA to allow for earlier approval of drugs that treat serious and life-threatening illnesses than would occur through the traditional approval program. Congress recently reiterated the importance and intent of the AAP pathway by strengthening the program in Sec. 3210 of the Consolidated Appropriations Act of 2023. For the six million individuals currently living with AD in the U.S., and for the millions at risk that will be diagnosed with the disease in the future, the development of effective therapies to prevent, delay, and better manage AD and related dementias is one of the most pressing and complex public health challenges facing our nation.
Now, the next move is in the hands of the Centers for Medicare and Medicaid Services (CMS) and we will be watching closely. The Alliance calls on CMS to rescind its current extreme barriers to coverage for anti-amyloid therapies. As the predominant insurer for individuals with Alzheimer’s disease, it is imperative that CMS provide immediate national coverage for Medicare beneficiaries.
The Alliance for Aging Research does not advocate on behalf of specific medical products (drug, therapy, device, etc.), and services, but for our society’s ability to accelerate the pace of scientific discoveries and their application to vastly improve the universal human experience of aging and health.