Washington, D.C. (June 13, 2023) – The Food and Drug Administration’s (FDA) Peripheral and Central Nervous System Drugs Advisory Committee unanimously endorsed the traditional approval of lecanemab. UsAgainstAlzheimer's applauded this resounding show of support, which demonstrates proper consideration of patient need in disease-modifying drug approvals.

UsAgainstAlzheimer's and its co-founder George Vradenburg submitted comments to the Advisory Committee on the patient experience, urgency, and clinical meaningfulness in relation to lecanemab. UsAgainstAlzheimer's released the following statement from Vradenburg in response to the news:

“This endorsement is the latest positive development on the path to what should be an inevitable conclusion: the era of slowing down Alzheimer’s is here. The unanimous result of this vote demonstrates confidence in the clinical benefit that patients need, making the urgency for access to this drug all the more important.

“What the committee recognized is the compelling nature of the data supporting this treatment. We know lecanemab slows the progression of Alzheimer’s—we also know an estimated 2,000 Americans progress from mild to moderate Alzheimer’s disease every day. That’s why we must act quickly to get patients access to these treatments while they can still reap the benefits.

“We congratulate the committee on taking patient needs seriously and encourage the broader FDA to act with the utmost haste in their final deliberations. We also look forward to the Centers for Medicare and Medicaid Services promptly providing coverage according to the label with no impediments to access for Medicare recipients.”
 

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 About UsAgainstAlzheimer's
UsAgainstAlzheimer's is engaged in a relentless pursuit to end Alzheimer’s, the sixth leading killer in America. Our work centers on prevention, early detection and diagnosis, and access to treatments – all regardless of gender, race, or ethnicity. To achieve our mission, we give voice to patients and caregivers while partnering with government, scientists, the private sector, and allied organizations -- the people who put the “Us” in UsAgainstAlzheimer’'.