The approval of Aduhelm by the FDA in June 2021 marked a controversial moment in Alzheimer’s disease treatment. Despite initial hopes, Aduhelm was eventually withdrawn from the market after it was found to be ineffective. The decision to approve the drug faced criticism and is seen as having negatively impacted Biogen’s reputation and possibly hindered progress in developing new treatments for Alzheimer’s.
On Tuesday, Roche announced positive results from a Phase I/II trial for its antibody trontinemab, signaling a significant development in the company’s ongoing efforts to address Alzheimer’s disease. After Aduhelm’s failure, Biogen partnered with Eisai to bring Leqembi to market, while Eli Lilly introduced Kisunla. Roche, which had previously experienced setbacks such as the failure of gantenerumab in 2022, continued research through its Genentech unit and contributed diagnostic tools that help patients access treatments like Leqembi and Kisunla.
Roche also advanced its Brainshuttle technology to improve delivery of medicine across the blood-brain barrier. Although challenges remain with monoclonal antibody therapies for Alzheimer’s—including diagnostic complexities and adjustments required by physicians—the field has progressed since Aduhelm's withdrawal.
Looking ahead, several important clinical readouts from Biogen and Lilly are expected soon. The presence of three major pharmaceutical companies—Biogen, Lilly, and Roche—in the Alzheimer’s space means that more patients may have access to effective treatment options.
"May 2026 be the year of the Alzheimer’s renaissance once again."
In related developments, both Lilly and Biogen are testing their anti-amyloid drugs on presymptomatic patients as they seek to expand their use beyond current populations. This approach could represent a shift in how doctors treat Alzheimer's if accepted by the medical community (https://www.biospace.com/article/as-biogen-nears-presymptomatic-alzheimer-s-readout-for-leqembi-can-doctors-be-convinced-/).
