FDA green light for Kevzara
Sanofi et Regeneron announced that the FDA had approved the Kevzara (sarilumab) for the treatment of polymyalgia rheumatica (PMR), in patients who have had an inadequate response to corticosteroids or who cannot tolerate corticosteroid tapering. This monoclonal antibody thus becomes the first and only biological product indicated for this pathology, one of the most common inflammatory rheumatic diseases.
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FDA reviews Biogen’s lecanemab
The health agency has accepted the filing of a Supplemental Biologics License (sBLA) application by Eisai et Biogen and granted priority review for approval of the This group (lecanemab-irmb) for the treatment of Alzheimer’s disease. In its phase III trial against early-stage Alzheimer’s disease, this monoclonal antibody reduced disease-related cognitive decline by 27%.
Good phase II results for Enhertu
L’get stronger (trastuzumab deruxtecan) met its endpoints in a phase II trial evaluating it in patients with previously treated, locally advanced, unresectable, or metastatic solid tumors that express HER2 and are not eligible for curative therapy . Developped by AstraZeneca et Daiichi Sankyothis drug is an antibody-drug conjugate, already approved for other indications in oncology.
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