Japan-based pharmaceutical company Eisai, a partner of Swedish biopharma company BioArctic AB (STO:BIOA-B), announced on Monday that it has submitted a supplemental Biologics License Application (sBLA) to the US Food and Drug Administration (FDA) for monthly lecanemab-irmb (US brand name: Leqembi) intravenous (IV) maintenance dosing.
Leqembi is indicated for the treatment of Alzheimer's disease (AD) in patients with mild cognitive impairment or mild dementia stage of disease (collectively referred to as early AD).
As part of the monthly IV maintenance regimen, the patients who have completed the biweekly IV initiation phase, exact period under discussion with the FDA, would receive a monthly IV dose that maintains effective drug concentration to sustain the clearance of highly toxic protofibrils which can continue to cause neuronal injury even after the amyloid-beta (A-beta) plaque has been cleared from the brain. The sBLA is based on modelling of observed data from the Phase 2b study (Study 201) and its open-label extension (OLE), as well as Clarity AD study (Study 301) and its OLE study.
Renew Biotechnologies names new chief operating officer
Teva, Sanofi accelerate inflammatory bowel disease drug trial
Ro adds David B Allison to Advisory Board
Charles River Laboratories and Autobahn Labs forge alliance to boost academic drug discovery
Nkarta partnering with Columbia on investigator-led lupus trial for NKX019
Gilead's lenacapavir demonstrates 100% efficacy in HIV prevention trial
Anixa Biosciences' ovarian cancer CAR-T therapy individual patient IND receives FDA approval
Evergreen Nephrology names new director
Emmaus Life Sciences names new chief executive officer
FDA feedback boosts Diamyd Medical's pathway to accelerated approval for Type 1 Diabetes Therapy
TC BioPharm (Holdings) doses sixth patient in TCB-008 clinical trial
Caidya names new chief executive officer
Ionis Pharmaceuticals reports positive results for ION582 in Angelman syndrome study
Nuvalent launches HEROEX-1 trial for HER2-selective inhibitor NVL-330
Astellas and Osaka University collaborate on stem cell therapy for disc degeneration