Biogen, Eisai Win Nod for Monthly Leqembi Maintenance Amid Stagnant Sales
The monthly maintenance regimen, which offers a more convenient frequency than the initially approved treatment schedule for patients with Alzheimer’s, could help with Leqembi’s thus far disappointing uptake and sales.
Eisai and Biogen’s LEQEMBI sBLA set for Alzheimer’s maintenance dosing
The FDA has approved the sBLA of Eisai and Biogen's LEQEMBI for maintenance dosing indicated for the early stages of Alzheimer's.
Biogen, Eisai Get FDA Nod for Leqembi IV Maintenance Dosing
Biogen and Eisai have won Food and Drug Administration approval of an intravenous maintenance dosing of their Leqembi drug for early Alzheimer's disease. The companies late Sunday said the FDA approved the maintenance dosing of once every four weeks after 18 months of the initiation phase of once every two weeks.
FDA Approves LEQEMBI® (lecanemab-irmb) IV Maintenance Dosing for the Treatment of Early Alzheimer’s Disease
Once every four weeks maintenance dosing may be 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 TOKYO and CAMBRIDGE,
Biogen/Eisai’s Alzheimer’s drug approved by FDA for monthly maintenance dosing
Biogen and Eisai’s Alzheimer’s disease (AD) drug Leqembi (lecanemab-irmb) has been approved by the US Food and Drug Administration (FDA) for monthly maintenance dosing. The anti-amyloid drug was granted traditional approval in the US in July 2023 for use as an intravenous (IV) infusion in patients with mild cognitive impairment or early-stage AD.
FDA Approves Once-Every-Four-Weeks Maintenance Dosing Of LEQEMBI For Early Alzheimer's Disease
Eisai Co., Ltd. (ESALF.PK) and Biogen Inc. (BIIB) announced Sunday that the U.S. Food and Drug Administration has approved the
Biogen lays out three FDA decisions that could ramp up Alzheimer's drug launch
Since its approval in 2023, the Alzheimer's disease drug made by Biogen Inc. and Eisai has seen a lackluster launch. However, Biogen CEO Chris Viehbacher said on Tuesday that there are a “number of catalysts” that could accelerate Leqembi’s growth in 2025.
US FDA OKs monthly maintenance dosing for Eisai/Biogen's Alzheimer's drug
The U.S. Food and Drug Administration has approved monthly maintenance dosing for Japan's Eisai and partner Biogen's Alzheimer's drug Leqembi, the companies said on Monday. The drug received standard U.
Verywell Health on MSN3d
Why It's Hard for Patients to Get the Newest Alzheimer's Drugs
Access to the new Alzheimer's drugs is limited by strict eligibility criteria, long wait times, and a lack of infusion ...
GlobalData on MSN13d
Eisai and Biogen’s subcutaneous Leqembi set for FDA review
Eisai and Biogen are one step away from deploying a more convenient version of their jointly developed Alzheimer’s treatment ...
Benzinga.com13d
FDA To Review Under the Skin Weekly Autoinjector For Biogen/Eisai's Alzheimer's Drug Leqembi
FDA sets August 31, 2025, as the action date for Eisai and Biogen's Leqembi subcutaneous autoinjector application.
FDA approves IV maintenance dosing of Leqembi® (lecanemab-irmb) for the treatment of early Alzheimer's Disease in the US
BioArctic AB (publ) (NASDAQ STOCKHOLM: BIOA B) today announced that the U.S. Food and Drug Administration (FDA) has approved BioArctic's partner Eisai's Supplemental Biologics License Application ...
Daily Reporter5d
‘LIFE-CHANGING’: Hancock Health begins offering new Alzheimer’s treatment
A new Alzheimer’s treatment at Hancock Regional Hospital has both doctors and patients feeling cautiously optimistic.