Just five months after the FDA granted Leqembi accelerated approval in January, the AdCom will debate the merits of a full-fledged approval on June 9, the FDA announced. The high-stakes AdCom could support Leqembi’s case to become the first monoclonal antibody to receive a full FDA approval for Alzheimer’s disease.
Biogen and Eisai hope new data from the positive Phase III CLARITY AD trial (NCT03887455) will boost the antibody’s approval prospects. CLARITY AD data was not available for consideration during the FDA’s previous accelerated approval decision.
In the 1,906-patient Phase III study, Leqembi met its primary endpoint – slowing clinical decline by 27% compared to placebo at 18 months. However, AdCom panelists may scrutinize the relatively modest effect size of Leqembi and the presence of the brain-swelling side effect known as ARIA (Amyloid Related Imaging Abnormalities) in participants.
Leqembi accelerated approval
On January 6, Leqembi received FDA accelerated approval based on its demonstrated effect on the surrogate marker of amyloid-beta (Aβ) reduction, which is thought to be a hallmark of Alzheimer’s disease progression.
In an 856-patient Phase II trial (NCT01767311), Leqembi statistically significantly reduced Aβ plaque levels in the brain. However, the Phase II study missed its efficacy endpoint, leaving a full approval out of the picture at the time of the FDA’s decision.
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The FDA can grant accelerated approval if it feels a drug’s effect on a surrogate marker like amyloid plaque is “reasonably likely” to predict clinical efficacy but requires additional studies to confirm the effect. FDA regulators do not have to follow the recommendations of independent AdComs, though they often do.
Alzheimer’s disease controversies
The FDA’s AdCom announcement comes as the Alzheimer’s disease drug development space is still reeling from controversy surrounding Biogen’s Aduhelm (aducanumab). The FDA granted Aduhelm accelerated approval for Alzheimer’s disease in 2021, despite an FDA AdCom overwhelmingly voting against approval.
The FDA’s surprising decision led to multiple AdCom members resigning in protest and a US congressional investigation into the FDA’s proceedings with Biogen. For its part, Aduhelm ultimately failed to gain any market traction after key US private and public insurers elected to significantly restrict coverage.