JCN Newswire14d
FDA Accepts LEQEMBI (lecanemab-irmb) Biologics License Application for Subcutaneous Maintenance Dosing for the Treatment of Early Alzheimer's Disease
Jan 15, 2025 - (JCN Newswire) - Eisai Co., Ltd. and Biogen Inc. announced today that the U.S. Food and Drug Administration (FDA) has accepted Eisai’s Biologics License Application (BLA) for ...
precisionmedicineonline15d
Biogen Says It's 'Doubling Down' on Alzheimer's Disease at JPM
Biogen in recent years has faced setbacks in this franchise as it struggled to market Aduhelm (aducanumab) amid a controversial ... from advancing another Alzheimer's candidate. Leqembi (lecanemab), ...
Seeking Alpha15d
Sarepta, Biogen drugs with accelerated approval under fire in FDA report
Leqembi (lecanemab). It also abandoned the required post-market study on Aduhelm. The OIG report points out that for both eteplirsen and aducanumab, FDA evaluated analyses were not included in the ...
Monthly Prescribing Reference16d
Lecanemab SC Formulation Under Review for Early Alzheimer Disease
A Prescription Drug User Fee Act target date of August 31, 2025 has been set for the application. The Food and Drug Administration (FDA) has accepted the Biologics License Application (BLA) for ...
Managed Healthcare Executive16d
FDA Accepts BLA for Leqembi Autoinjector
The FDA has set a goal date of Aug. 31, 2025. The FDA has accepted a biologics licensing application (BLA) for Eisai’s Leqembi (lecanemab-irmb), a subcutaneous 100 mg/mL weekly autoinjector for the ...
clinicaltrialsarena17d
ProMIS Neurosciences launch Phase Ia AβO Alzheimer’s trial
and Eisai and Biogen’s Leqembi (lecanemab). Both drugs act by removing amyloid plaques from a patient’s brain to slow the progression of the disease. Eisai and Biogen also developed another monoclonal ...
Salon19d
Why Alzheimer’s scientists are rethinking the amyloid hypothesis
In June 2021, the Food and Drug Administration approved aducanumab, an amyloid beta ... It offers similar efficacy to lecanemab and comparable safety risks. To Eric Widera, a professor of medicine ...
The Lancet21d
Advances in dementia research and clinical care in 2024
Experience with lecanemab in clinical practice, reported at the 2024 Clinical Trials in Alzheimer Disease conference in Madrid, Spain, found safety results for AATs similar to what was reported in ...
Undark23d
Why Alzheimer’s Scientists Are Re-thinking the Amyloid Hypothesis
In June 2021, the Food and Drug Administration approved aducanumab, an amyloid beta-targeted drug ... It offers similar efficacy to lecanemab and comparable safety risks. To Eric Widera, a professor ...
pharmaphorum25d
Biogen, Eisai say lecanemab has aced phase 3 Alzheimer's study
Aside from dubious efficacy data, Aduhelm has also been held back by the risk of side effects – known as amyloid-related imaging abnormalities (ARIA) – that were also more common with ...
Daily Herald25d
As a doctor, here’s what I have learned from my own Alzheimer’s disease
After only four monthly injections of aducanumab (a cousin of lecanemab) during the phase 3 trial, I developed swelling and bleeding in my brain requiring a stay in an intensive care unit and ...