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FDA Accepts UCB’s sBLA for 2 mL Bimzelx Device

The U.S. Food and Drug Administration (FDA) also accepted a second sBLA from UCB for the bimekizumab-bkzx (Bimzelx, UCB) 2mL device. Today, one dose of Bimzelx in moderate-to-severe plaque psoriasis is administered as two 1mL injections. Approval of the 2mL device presentations would mean that patients would have an alternative dosing regimen, explains Jeffrey Stark, MD, VP and Head of Medical Immunology, UCB.