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.
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.”