HQ Team
January 28, 2025: Biogen Inc. and its Japanese partner, Eisai Co. Ltd., announced that the US regulator had approved four-weekly maintenance dosing for its Alzheimer’s drug.
Intravenous Lecanemab-irmb, branded as Leqembi, was greenlighted by the US Food and Drug Administration for treating Alzheimer’s disease in patients with mild cognitive impairment or mild dementia stage of the disease.
Patients can transition to once every-four weeks maintenance dosing after 18 months of once every-two weeks treatment “to maintain clinical and biomarker benefits of therapy,” according to Biogen.
The drug rapidly clears sticky protein deposits or plaque that damage the neurons and affect the cognitive function in the brain. It has safety warnings regarding potential brain swelling and bleeds. Patients are recommended to undergo monitoring with scans.
Slow disease progression
Once every four weeks, maintenance dosing may make it easier for patients and care partners to continue treatment. Alzheimer’s disease progression does not stop after plaque clearance. Ongoing treatment with Leqembi can slow disease progression and prolong the benefits of therapy, according to Tokyo-headquartered Eisai.
Leqembi is approved in the US, Japan, China, South Korea, Hong Kong, Israel, UAE, Great Britain, Mexico and Macau. The drug received standard US approval in 2023.
Those approvals were based on end-stage clinical trial data which met its primary endpoint and all key secondary endpoints with “statistically significant results.”
In November 2024, the treatment received a positive opinion from the Committee for Medicinal Products for Human Use of the European Medicines Agency, recommending approval.
PDUFA action date
Eisai has submitted applications for approval of lecanemab in 17 countries and regions.
The US drug regulator has accepted Eisai’s Supplemental Biologics License for the drug’s subcutaneous autoinjector for weekly maintenance dosing in January 2025 and set a PDUFA action date for August 31, 2025.
Eisai and Biogen have been collaborating on the joint development and commercialisation of Alzheimer’s treatments since 2014.
Eisai serves as the lead of lecanemab development and regulatory submissions globally with both companies co-commercializing and co-promoting the product and Eisai having final decision-making authority.
BioArtic pact
Since 2005, Eisai and BioArctic have had a long-term collaboration regarding the development and commercialisation of Alzheimer’s treatments.
Eisai obtained the global rights to study, develop, manufacture and market lecanemab for the treatment of the disease after an agreement with BioArctic in December 2007. The development and commercialisation agreement on the antibody lecanemab back-up was signed in May 2015.
Alzheimer’s disease is a brain disorder that slowly destroys memory and thinking skills, and eventually, the ability to carry out the simplest tasks.
In most people with Alzheimer’s, symptoms first appear later in life. Estimates vary, but experts suggest that more than 6 million Americans, most of them age 65 or older, may have Alzheimer’s.
