The Food and Drug Administration (FDA) has approved the supplemental Biologics License Application (sBLA) for the monthly intravenous (IV) maintenance regimen of Leqembi ® (lecanemab-irmb ...

The FDA has accepted Eisai and Biogen’s biologics license application for a subcutaneous autoinjector weekly maintenance dose of Leqembi for patients with mild cognitive impairment or mild ...

However, Biogen CEO Chris Viehbacher said on Tuesday that there are a “number of catalysts” that could accelerate Leqembi’s growth in 2025. Since its approval in 2023, the launch of the ...

EMA approval of the Alzheimer’s disease therapy Leqembi (lecanemab) has stalled once again, after the European Commission did not as usual nod through the agency’s recommendation, but told it to ...

Key contributors included LEQEMBI with a 28.1 billion yen increase, Lenvima with 24.9 billion yen growth, and Dayvigo up by 9.3 billion yen. Naito emphasized significant milestones for LEQEMBI ...

1,2,3 Only LEQEMBI works to fight AD in two ways: continuously clearing protofibrils and rapidly clearing plaque. This is important because with continuous administration, LEQEMBI clears highly ...

Simply shifting one vial of the anti-amyloid antibody from ... Similar concerns have also been raised with rival anti-amyloid drug Leqembi (lecanemab) from Eisai/Biogen and have blocked its ...

The European Medicines Agency (EMA) announced it will review new safety data on the Alzheimer’s disease drug Leqembi (lecanemab). This follows a prior decision to recommend its use in the ...

Eisai and Biogen are one step away from deploying a more convenient version of their jointly developed Alzheimer’s treatment Leqembi (lecanemab-irmb) after the US Food and Drug Administration ...

FDA sets August 31, 2025, as the action date for Eisai and Biogen's Leqembi subcutaneous autoinjector application. Leqembi's subcutaneous dosing allows Alzheimer's patients to administer weekly ...

Alzheimer's disease progression does not stop after plaque clearance; ongoing treatment with LEQEMBI can slow disease progression and prolong the benefits of therapy TOKYO and CAMBRIDGE ...

Leqembi is indicated for the treatment of Alzheimer's disease in patients with mild cognitive impairment (MCI) or mild dementia stage of disease in the U.S. (early Alzheimer's disease).