Lilly’s Donanemab Could Be A Near-Term Aduhelm Competitor

There could be at least two amyloid-clearing antibodies for Alzheimer’s disease on the market in the US next year if Eli Lilly and Company succeeds in its pursuit of accelerated approval for donanemab. Lilly said on 24 June that the US Food and Drug Administration granted a breakthrough therapy designation for donanemab based on Phase II results reported earlier this year and that, following the accelerated approval for Biogen, Inc./Eisai Co., Ltd.’s Aduhelm, it plans to file a biologic license application with the agency based on the Phase II data later this year.

When the FDA revealed its controversial accelerated approval of Biogen/Eisai’s Aduhelm (aducanumab) on 7 June, the agency said its decision relied on a surrogate endpoint in the companies’ Phase III trials – the antibody’s ability to clear amyloid from the brain of Alzheimer’s patients. The approval created speculation that other companies with amyloid-clearing therapies would pursue accelerated approvals as well; Lilly’s announcement indicates that door is open