FDA – Last Week in Review

Last week, the US Food and Drug Administration (FDA) made key decisions regarding the approval of multiple medications and accepted submissions of a few others. First, the agency approved the use of semaglutide as a first-line diabetes therapy. In addition, it accepted the application for brexpiprazole in treating agitation related to Alzheimer’s disease. It wasn’t the only application for the treatment of the otherwise intractable disease.

According to Denise Myshko, “Just after receiving accelerated approval for Leqembi (lecanemab-irmb) to treat patients with early Alzheimer’s disease, Eisai/Biogen have submitted a supplemental biologics license application (sBLA) for full approval. Leqembi is humanized immunoglobulin gamma 1 (IgG1) monoclonal antibody directed against aggregated soluble and insoluble forms of amyloid beta.”

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(Source: Managed Healthcare Executive, January 14^th, 2023)