Urges FDA to do a thorough and accelerated review of donanemab and lecanemab when the drugs are submitted for approval

Washington, D.C. (June 24, 2021) – UsAgainstAlzheimer’s today issued the following statement from George Vradenburg, chairman and co-founder, on announcements related to two new drug treatments. Eli Lilly said today that will apply for Food and Drug Administration (FDA) accelerated approval this year for its experimental Alzheimer's drug donanemab. In addition, the FDA has granted breakthrough therapy designation to Eisai’s and Biogen’s experimental therapy, lecanemab, for patients with early Alzheimer's. Both drug therapies seek to reduce amyloid plaques in the brain, but do so in different ways.

“These announcements show that the FDA has declared war on Alzheimer’s and offer the promise of more treatment choices to patients and families. We believe that more choices will lead to even greater competition on innovation and price, which will improve treatments and make them more affordable and accessible to people who need them.

“At the same time, we think much more attention must be paid to equity and inclusion in Alzheimer’s drug development. The clinical trials for both Biogen’s aducanumab and Lilly’s donanemab had dismal representation from Black Americans, Latinos, and other people of color at high risk of Alzheimer’s. Future clinical trials on these drug therapies must set and meet inclusion and equity targets to ensure that communities of color are represented at levels equal to their proportion of the Alzheimer’s population.

“We are pleased to see the FDA taking into account the needs and views of patients as it considers Alzheimer’s treatments. Just a few short weeks ago, Alzheimer’s patients had no options at all for a treatment. Now patients have the approval earlier this month of aducanumab as the first Alzheimer’s therapy in nearly 20 years, with these new developments with donanemab and lecanemab offering new signs of hope on the horizon.

“We urge the FDA to give priority review when donanemab and lecanemab are submitted for regulatory review.”

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About UsAgainstAlzheimer’s

UsAgainstAlzheimer’s exists to conquer Alzheimer’s disease. We take on the toughest problems; bring all of “Us” together to break down barriers; advocate for research that will speed treatments to market; and drive changes that matter most to people living with the disease. We will not rest until brain-span equals lifespan - for everyone.