Biogen, FDA and Eisai

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 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.
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).
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.
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 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 Alzheimer disease administered Leqembi.
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
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.
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 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
U.S. regulator OKs Eisai-Biogen Alzheimer's drug's continuous dosing
Japanese pharmaceutical company Eisai Co. and U.S. firm Biogen Inc. said Monday that a jointly developed Alzheimer's drug has been approved for continuous use for people with early stages of the disease by U.
Merck and Eisai's cancer drugs fail to improve overall survival in late-stage trial
Merck's blockbuster drug Keytruda and Eisai's cancer drug Lenvima, in combination with chemotherapy, failed to improve ...
GlobalData on MSN3d
MSD and Eisai’s LEAP gastroesophageal cancer trial sees mixed success
MSD and Eisai’s trial saw mixed success with its two primary endpoints, seeing success in progression-free survival, but ...
The Pharma Letter1h
Keytruda and Lenvima trial fails to show OS benefit
Results have been announced from a Phase III trial of Merck & Co’s anti-PD-1 therapy Keytruda (pembrolizumab) plus Lenvima ...
Zacks.com on MSN3h
MRK Reports Mixed Keytruda Combo Study Data in Gastroesophageal Cancer
Merck MRK along with partner Eisai announced data from the phase III LEAP-015 study, which evaluated blockbuster PD-1 ...
BioPharma Dive3d
Mixed results for Keytruda; AbbVie to work with Neomorph
Merck and Eisai reported new data for a drug regimen of Keytruda and Lenvima. Elsewhere, AstraZeneca expanded in Canada and ...