Statement by Healthcare Leadership Council President Mary R. Grealy on FDA Approval of Treatment for Alzheimer’s Disease
There are few diseases more cruel and painful for patients and their loved ones than Alzheimer’s Disease. For millions of Americans who are and will be afflicted with this disease, the Food and Drug Administration’s decision to grant approval for the first novel therapy for Alzheimer’s in nearly 20 years, one that shows a reasonable likelihood to slow clinical decline in patients, brings a long-awaited measure of hope.
We can draw two important conclusions from today’s announcement. First, the FDA’s Accelerated Approval Pathway, which was utilized to approve Biogen’s Aduhelm treatment, is a vital asset for patients who have serious health conditions and unmet needs. Patients with Alzheimer’s and their loved ones will welcome the opportunity to have this treatment even as studies continue. Also, the creation of this treatment further underscores that we are living in a golden age of biomedical innovation with new treatments, cures and vaccines emerging from development pipelines with inspiring frequency. This strengthens the argument that policymakers must encourage this type of game-changing research in order to elevate population health and improve and extend lives.
(Biogen is a member of the Healthcare Leadership Council.)