GAP President John Dwyer wrote to the FDA in support of the Aducanumab drug developed by Biogen.
Dear Dr. Woodcock,
On behalf of the Global Alzheimer’s Platform Foundation (GAP) and millions of Alzheimer’s patients and caregivers across the nation, I urge the Food and Drug Administration (FDA) to approve aducanumab for treatment of early stage Alzheimer’s Disease. Aducanumab offers disease-modifying benefit significantly exceeding current therapies. It will provide long-overdue and much-needed help to people fighting this horrible disease.
My opinion concerning the advantages of Aducanumab was further solidified during a webinar on February 23, 2021 facilitated by GAP that allowed Biogen to present data and respond to questions gathered by GAP that were submitted by our network of Alzheimer’s research sites and well-known Alzheimer’s key opinion leaders. The data were presented transparently, cogently and appeared consistent with FDA guidance. This webinar had nearly 300 attendees and Biogen addressed specific questions about their clinical trial data as well as several questions about clinical use of aducanumab if FDA approval is granted.
Alzheimer’s patients have been therapeutically orphaned for nearly 20 years. This void should be filled when there is a significant possibility of obtaining the first treatment that can slow the disease and extend patients’ quality of life.
In general, patients and their physicians should make treatment decisions based on their informed judgment about the best course of care. Patients facing early Alzheimer’s, their families, and their doctors deserve the ability to consider whether aducanumab will deliver the best medical outcome and quality of life.
FDA clinical reviewers found that aducanumab noticeably slowed decline in six critical clinical aspects of patients’ lives, including cognition and functional independence. The FDA’s review notes that results from aducanumab trials were “highly persuasive” and the study demonstrated “substantial evidence of effectiveness.” In addition, the data demonstrate that aducanumab is safe for patients to use.
Aducanumab is not a cure, but it does slow the progression of Alzheimer’s in a significant portion of patients who are appropriately dosed. In fact, one analysis indicates that aducanumab will benefit more than 60 percent of the patients who take it. That represents a substantial benefit to millions of people who otherwise have no therapeutic option to slow the disease.
We applaud the FDA’s approach to public engagement and GAP is proud to have furthered quality discussions by facilitating webinar updates between Biogen and leading Alzheimer’s researchers. We appreciate that the FDA has been transparent and energetic in its collaboration with a broad range of stakeholders, including patient advocates, researchers, and pharmaceutical companies. Close collaboration with knowledgeable stakeholders in the private and public sectors is essential for well-informed, timely decision making by the FDA.
To be clear, the core, unprecedented benefit conferred by aducanumab is more time. More time with families, more time with loved ones, more time to live independently and more time to receive the next generations of Alzheimer drugs.
As you and your staff complete your review of the clinical evidence, we respectfully request that the FDA approve this therapy on behalf of the millions of people with Alzheimer’s who have no therapy and deserve hope. After aducanumab is approved, we would welcome a surveillance study to inform how to optimize patient selection and the administration of the drug.
Global Alzheimer’s Platform Foundation
1101 K Street NW, Suite 400
Washington, DC 20005