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

Company Will File For Accelerated Approval

Jun 24 2021

• By Mandy Jackson

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Lilly said it will seek accelerated approval in the US based on Phase II data for its amyloid-clearing antibody, potentially narrowing Biogen/Eisai’s newly approved therapy Aduhelm’s time on the market as the only disease-modifying Alzheimer’s drug.

Amyloid plaques forming between neurons — The amyloid plaque surrogate endpoint behind Aduhelm's accelerated approval could benefit donanemab and other drugs • Source: Alamy

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...

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