FDA nod for UCB’s 320 mg single-injection Bimzelx for psoriasis

14 October 2024

The US Food and Drug Administration (FDA) has approved a 2mL pre-filled syringe and pre-filled autoinjector, each containing 320mg of Belgian drugmaker UCB’s (Euronext: UCB) Bimzelx (bimekizumab-bkzx), to treat psoriasis.

These new device presentations add to the currently available 1 mL administration options, each containing 160mg of the humanized IgG1 monoclonal antibody, and mean that patients requiring a 320mg dose will have options for single-injection administration.                     

Emmanuel Caeymaex, executive vice president, head of patient impact, chief commercial officer, added: “Our goal with these single-injection regimens is to strengthen and expand administration options, increase convenience and enhance the individual patient experience.                                                                                                                                                                                                                                         

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