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FDA Fast-Tracks Alzheimer’s Drug Lecanemab; Decision Expected By Early 2023

By Simon Spichak, MSc | July 7th, 2022

Biogen and Eisai’s next disease-modifying Alzheimer's drug candidate, lecanemab, has been granted FDA priority review, signaling that a decision could be made by early next year.

According to an Eisai press release, the U.S. Food and Drug Administration has now granted priority review to a new anti-amyloid drug by Biogen and Eisai, lecanemab, for the treatment of Alzheimer’s disease. The FDA expressed an intention to announce their decision by January 6, 2023.

The drugmakers’ previous anti-amyloid drug, Aduhelm, became the first FDA-approved treatment for Alzheimer’s developed as a disease-modifying therapy in June, 2021. More than a year later, this approval remains controversial as experts continue to question Aduhelm’s safety and efficacy. Meanwhile, regulatory agencies around the world have declined to approve it, and many major U.S. hospitals have declined to offer it.

(In February 2024, Biogen took Aduhelm off the market indefinitely.)

Like Aduhelm (aducanumab), lecanemab also targets amyloid proteins in the brain, and is also designed to fundamentally modify the disease pathology of Alzheimer’s. Findings from Phase 2 clinical trials suggest that lecanemab’s anti-amyloid removing activity was linked to a slowing of cognitive decline. Based on this early trial data, the drug also appears to be safer, with three times fewer incidences of amyloid-related imaging abnormalities (ARIA), a common side effect of Aduhelm, as compared to Aduhelm.

More study is needed to confirm these findings. Results from lecanemab’s ongoing Phase 3 clinical trial are expected to be released in the fall of 2022.

“The acceptance of lecanemab’s BLA [Biologics License Application] with priority review is an important milestone in serving people living with Alzheimer’s disease who have been waiting for new treatment options,” Eisai CEO Haruo Naito said in a statement. We will continue to actively cooperate with the FDA’s review in an effort to bring this new treatment option to people living with Alzheimer’s disease and their families as soon as possible.”

UPDATED: 3 March 2024, 8:46 P.M. ET. In February 2024, Biogen took Aduhelm off the market, citing financial concerns. Although the drug did receive accelerated, conditional FDA approval for the treatment of early Alzheimer’s disease in 2021, it is no longer available to new patients. The company announced it would sunset trials in May 2024 and cease supplying the drug to current patients in November 2024.

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3 thoughts on “FDA Fast-Tracks Alzheimer’s Drug Lecanemab; Decision Expected By Early 2023

  1. I just wanted to say that I prayed for a new drug for Altimzer.My dad has it now.i hope it will help him,Amen

  2. Please keep working towards the cure of this dreaded disease. I pray daily for the health of all affected including my 58 year old wife ,God bless her. Thank you.

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