Washington, D.C. (January 27, 2021) – John Dwyer, President of the Global Alzheimer’s Platform Foundation® (GAP), a person-centric non-profit organization committed to accelerating the discovery of therapies for the treatment of Alzheimer’s, applauded the announcement today by Biogen Inc. that it would ensure that at least 18 percent of participants in its FDA mandated study will be from diverse populations.
“Clinical trials of Alzheimer’s therapeutics commonly only include 2-3 percent of African American and Latino individuals in the studies. Today’s announcement by Biogen—a leading global biotechnology company—to enroll 18 percent of the trial participants from African American and Latino communities for their ENVISON confirmatory study for Aduhelm, the first and only Alzheimer’s disease modifying treatment to address the disease, is a significant step towards giving these communities access to a drug that treats a disease that ravages their families and friends. It should be the baseline goal for all drug manufacturers across all diseases. We commend the efforts by Biogen to improve equity in medical research and treatment for America’s most vulnerable patients.
Older African American and Latino Americans are twice and one-and-a-half times more likely, respectively, to have Alzheimer’s or other dementias—so Biogen’s announcement today takes direct aim at addressing inequities in health research for these disproportionately affected communities.
This pledge from Biogen comes on the heels of GAP’s own efforts to bring attention to the critical need to improve clinical trial participation for underrepresented groups. GAP’s very own Bio-Hermes trial made an immutable commitment to ensure that 20 percent of the African American and Latino community is represented in clinical trials. Bio-Hermes is on pace to reach or exceed this goal later this year.
For the first time in nearly 20 years, Alzheimer’s patients could access an FDA approved therapy — a therapy for a condition that has no other treatment. At the urging of GAP and other patient groups, Biogen has taken steps to address the access issue by substantially reducing the drug’s price and now has committed to enrolling populations that are more representative of the population living with Alzheimer’s, working to ensure that future Alzheimer’s therapies are inclusive for all affected by this scourge.
It is now time for CMS to reimburse the cost of this drug, as it has for all similarly FDA-approved treatments for various other diseases, so that millions of Alzheimer’s patients might benefit. Do not make us wait any longer.”
About the Global Alzheimer’s Platform Foundation® (GAP)
The Global Alzheimer’s Platform Foundation® (GAP) is a person-centric nonprofit dedicated to?accelerating?the delivery of innovative therapies for neurological disorders by reducing the?duration?and cost of clinical trials. Research centers?across the US, Canada, and Europe?are part of the growing GAP Network (GAP-Net). GAP supports?GAP-Net research centers by assisting with?study start up and recruitment activities,?promoting?diversity in research studies, and?offering?international clinical trial infrastructure, resources, and programs that champion brain health and the citizen scientists who make research possible.