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Biogen, Eisai and Leqembi
Eisai and Biogen’s Leqembi sBLA set for Alzheimer’s maintenance dosing
The US Food and Drug Administration has approved the supplemental biologics licence application (sBLA) of Eisai and Biogen's Leqembi (lecanemab-irmb) for maintenance dosing once every four weeks for the early stages of Alzheimer's disease.
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.
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.
Eisai and Biogen gain FDA approval for monthly Leqembi
Eisai and Biogen have secured US Food and Drug Administration approval for a once-monthly intravenous maintenance dosing regimen for Leqembi (lecanemab).
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 treatmentAlzheimer's disease progression does
BIIB Secures FDA Nod for Monthly Maintenance Dosing of Alzheimer's Drug
The FDA's approval is based on simulation data from multiple studies showing that maintenance dosing with Biogen???s Leqembi every four weeks prolongs biomarker benefits.
Biogen, Eisai receive FDA nod for monthly Leqembi IV maintenance dosing
The Japanese and American based pharma companies announced a win for their Alzheimer’s treatment, which has faced some negative backlash over the last year.
FDA approves Eisai, Biogen’s sBLA for lecanemab-irmb IV dosing
Eisai (ESAIY) and Biogen (BIIB) announced that the U.S. Food and Drug Administration, FDA, has approved the Supplemental Biologics License
FDA approves Leqembi four-week maintenance dosing
The FDA has approved Eisai (OTCPK:ESALF) and Biogen's (NASDAQ:BIIB) supplemental application for four-week maintenance dosing of their Alzheimer's drug Leqembi. The agency approved Leqembi to be dosed every four weeks via IV as a maintenance therapy.
STAT
2d
U.S. health agencies see some chaos — but an FDA approval gets through
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Eisai and Biogen Announce FDA Approval for Once Every Four Weeks Maintenance Dosing of LEQEMBI for Alzheimer's Disease Treatment
Eisai
and Biogen announced FDA approval for
LEQEMBI
’s once every four weeks maintenance dosing for Alzheimer’s disease treatment.
Eisai
Co., Ltd. and Biogen Inc. announced that the U.S. FDA ...
devdiscourse
1d
Global Health Headlines: Profit Surges, Flu Cases, and Policy Shifts
Recent health news includes a profit boost for Swedish manufacturer Getinge, a human case of bird flu detected in the UK, and ...
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