Europe to review safety data for Eisai-Biogen Alzheimer's drug
The European Commission has requested its medicines regulator to consider safety information on Eisai and Biogen's Alzheimer's drug Leqembi, the agency said on Friday. The safety information to be reviewed was made available after November,
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.
FDA Approves New Maintenance Dosing for Lecanemab to Treat Early-Stage Alzheimer Disease
The FDA approves a new maintenance dosing regimen for lecanemab (Leqembi; Eisai) in patients with early-stage Alzheimer disease (AD), enabling a transition from biweekly to once-every-4-week dosing while preserving clinical and biomarker benefits.
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.
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
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New Maintenance Dosing Option for Alzheimer's Drug Leqembi Offers Flexibility
Fact checked by Nick Blackmer The Food and Drug Administration (FDA) has approved a new maintenance dosing schedule for ...
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Update on Regulatory Review of Lecanemab for Early Alzheimer’s Disease in the European Union
Viehbacher, “Biogen”) announced today an update on the ongoing regulatory review of the Marketing Authorization Application for lecanemab as treatment for early AD (mild cognitive impairment due to ...
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Leqembi Monthly IV Maintenance Dosing Approved for Early Alzheimer Disease
Lecanemab is a humanized immunoglobulin gamma 1 monoclonal antibody directed against aggregated soluble and insoluble forms of amyloid beta.
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 ...
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 ...
PharmaTimes3d
FDA approves new Alzheimer’s treatment regimen
The US Food and Drug Administration (FDA) has approved Eisai and Biogen’s Supplemental Biologics License Application for once ...
Verywell Health on MSN6d
What's New in Alzheimer's Treatment?
We now have two FDA-approved disease-modifying treatments for Alzheimer's disease, and hundreds of clinical trials are ...
Pharm Exec3d
FDA Approves Supplemental Biologics License Application for Intravenous Maintenance Dosing of Leqembi in Alzheimer Disease
Approval was based on results from multiple studies, which demonstrated a slowing of cognitive decline in patients with ...
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U.S. health agencies see some chaos — but an FDA approval gets through
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