Biogen/Eisai’s Alzheimer’s drug backed by FDA advisory committee for traditional approval

Biogen and Eisai’s Alzheimer’s disease drug has been recommended for traditional approval by a US Food and Drug Administration (FDA) panel of experts.

The Peripheral and Central Nervous System Drugs Advisory Committee (PCNS) voted unanimously that data from Eisai’s late-stage trial confirmed the benefit of Leqembi (lecanemab-irmb) for those at an early stage of the disease.

The drug was authorised for use earlier this year through the accelerated approval pathway, under which the FDA may approve drugs for serious conditions where there is an unmet medical need.

This decision was based on phase 2 data showing that Leqembi reduced the accumulation of amyloid beta plaque in the brain, a defining feature of Alzheimer’s disease.

Christopher Viehbacher, president and chief executive officer of Biogen, said at the time: "The approval of Leqembi provides new hope to patients with Alzheimer’s disease. Patients at an early stage of the disease and their caregivers can now consider a new treatment option with their doctors.”

Eisai’s supplemental biologics application for approval under the traditional pathway is supported by data from its phase 3 confirmatory Clarity AD clinical trial.

The study met its primary endpoint, reducing clinical decline by 27% on the global cognitive and functional scale – Clinical Dementia Rating-Sum of Boxes – compared with placebo at 18 months.

All multiplicity-controlled secondary endpoints also showed highly statistically significant results compared with placebo, the companies said, including other measures of cognition and daily function.

The FDA will now consider the panel’s advice as it works towards completing its review of Leqembi by 6 July, with a traditional approval likely to expand Medicare payment for the drug.

Affecting more than 6.5 million Americans, Alzheimer’s disease is an irreversible, progressive brain disorder that slowly destroys memory and thinking skills and, eventually, the ability to carry out simple tasks. Current treatments only treat symptoms but do not change the course of the disease.

Joanne Pike, president and chief executive officer of the Alzheimer’s Association, commented: “[The organisation] welcomes and celebrates this action by the FDA advisory committee to support traditional approval of Leqembi for people with early Alzheimer’s.

“With this action we are one step closer to more people living with Alzheimer’s having more time with more of their capabilities intact – to do the things they want to do and love to do best.”