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Biogen and Eisai’s Alzheimer’s drug receives FDA accelerated approval

An application has also been submitted for US approval under the traditional pathway


Biogen and Eisai’s Leqembi (lecanemab-irmb) has been approved by the US Food and Drug Administration (FDA) under the accelerated approval pathway to treat Alzheimer’s disease.

Specifically, Leqembi is indicated for patients with mild cognitive impairment or mild dementia stage of disease, the population in which treatment was initiated in clinical trials.

The FDA’s 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.

"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," said Christopher Viehbacher, president and chief executive officer of Biogen.

Eisai has also submitted a supplemental biologics application (sBLA) to the FDA for approval under the traditional pathway, the companies said.

The sBLA is based on data from the phase 3 confirmatory Clarity AD clinical trial. The study met its primary endpoint and reduced clinical decline by 27% on the global cognitive and functional scale – Clinical Dementia Rating-Sum of Boxes – compared with placebo at 18 months.

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

Haruo Naito, chief executive officer at Eisai, said: “The fact that Eisai was able to file Leqembi’s sBLA for traditional FDA approval on the same day we received accelerated approval demonstrates our commitment to the Alzheimer’s disease community and is a major step forward in ensuring access for all those in the US living with this disease in need of this medicine. We will continue to actively cooperate with the FDA's review.”

The Japanese company said it also planned to apply for marketing authorisation for Leqembi in Japan and the EU by the end of its business year on 31 March, with the aim of receiving an approval from the Japanese authority by the end of this year.

Eisai and Biogen have been collaborating on the joint development and commercialisation of Alzheimer’s disease treatments since 2014. Eisai is the leader in lecanemab development and regulatory submissions globally, with both companies co-commercialising and co-promoting the product and Eisai having final decision-making authority.

Article by
Emily Kimber

9th January 2023

From: Regulatory



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