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A few days ago, Biogen and Eisai are actively promoting the approval of the second Alzheimer's disease drug lecanemab (BAN2401) by the U.
S.
Food and Drug Administration (FDA)
.
Eisai said in its latest quarterly earnings report that the two companies have begun communicating with the US FDA to achieve the "best regulatory approach" for lecanemab's approval
.
The drug is an investigational anti-amyloid beta fibril antibody.
The drug was originally jointly developed by Eisai and BioArctic
.
In March 2014, Eisai and Bojian reached a cooperation to jointly develop lecanemab
The US FDA granted lecanemab breakthrough therapy designation, mainly based on the positive results of the Phase IIb clinical trial Study 201
.
The test results show that the highest dose (10 mg/kg) of lecanemab can significantly reduce the amyloid level in the patient's brain
In July, Biogen and Eisai announced the initiation of the Phase III AHEAD3-45 trial in the United States.
The purpose is to evaluate the efficacy of lecanemab in asymptomatic patients with early Alzheimer's disease who have increased brain amyloid levels, with approximately 1,795 Three subjects were enrolled in the group
.
Eisai and Bojian completed the registration of the trial in March 2021, and it is expected that the main endpoint of the study will be achieved by the end of September 2022
Although Eisai and Biogen are seeking the FDA to accelerate the approval of lecanemab, Aduhelm, the first approved Alzheimer's disease drug, is facing the dilemma of constant controversy
.
In June of this year, Aduhelm developed by Biogen and Eisai was approved by the FDA, becoming the first approved drug for Alzheimer's disease in the United States in the past 20 years
Reference source: Eisai and Biogen Gun for Speedy Approval for Another Alzheimer's Drug
