Aztreonam lysine

BioArctic AB (publ) has announced that the US Food and Drug Administration (FDA) has accepted BioArctic's partner Eisai's Biologics License Application (BLA) for Leqembi subcutaneous autoinjector (SC-AI) for weekly maintenance dosingLeqembi is indicated for the treatment of Alzheimer's disease (AD) in patients with Mild Cognitive Impairment (MCI) or mild dementia stage of disease (collectively referred to as early AD). Leqembi is the only FDA-approved anti-amyloid therapy that potentially could offer the convenience of a subcutaneous injection with at-home administration option. The Prescription Drug User Fee Act (PDUFA) action date has been set to August 31, 2025. The BLA is based on data from the Clarity AD (Study 301) open-label extension (OLE) and modelling of observed data. If LEQEMBI subcutaneous maintenance dosing is approved by the FDA, LEQEMBI will be the only treatment for AD that can be administered subcutaneously at home using an autoinjector (AI). The injection process is expected to take, on average, 15 seconds. The SC-AI 360 mg weekly maintenance regimen will allow patients who have completed the biweekly intravenous (IV) initiation phase, exact period under discussion with the FDA, to receive weekly doses that are expected to maintain the clinical and biomarker benefits. The SC-AI is expected to be simple and easy for patients and their care partners to use, and may reduce the need for hospital or infusion site visits and nursing care for IV administration, which will make it easier to continue maintenance administration and may contribute to further simplifying the treatment pathway for AD. Leqembi is already approved in the US, Japan, China, Great Britain and other markets. In November 2024, the treatment received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) recommending approval.