UCB’s BIMZELX[®]▼ (bimekizumab) 320 mg Device Earns Favorable CHMP Opinion

UCB, a leading global biopharmaceutical company, has announced today that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has rendered a favorable opinion, recommending the authorization for two new device presentations of bimekizumab. These presentations include a pre-filled syringe and a pre-filled pen, both containing 320 mg of bimekizumab in a 2 mL volume.

Emmanuel Caeymaex, UCB’s Executive Vice President and Head of Patient Impact, emphasized the significance of these new device options, stating that they are designed to improve the patient experience. If approved, these presentations would streamline the administration process, offering patients the convenience of a single injection of the 320 mg dose of bimekizumab.

Currently approved in the European Union (EU) as a 160 mg solution for injection in pre-filled syringe and pre-filled pen forms, each with a total volume of 1 mL, bimekizumab’s recommended dose for the treatment of moderate to severe plaque psoriasis or active moderate to severe hidradenitis suppurativa is 320 mg. This dose is administered as two 1 mL injections. The new device presentations would provide an alternative option for single-injection administration of the 320 mg dose in a 2 mL volume.

The CHMP’s positive opinion stems from studies evaluating the bioequivalence of bimekizumab 320 mg administered as one 2 mL subcutaneous injection versus two 1 mL subcutaneous injections in healthy study participants.

The recommendation by CHMP will undergo review by the European Commission (EC) for marketing authorization in the European Union and the countries of the European Economic Area. A final decision is anticipated within approximately two months.

Bimekizumab, a humanized monoclonal IgG1 antibody, selectively inhibits interleukin 17A (IL-17A) and interleukin 17F (IL-17F), crucial cytokines involved in inflammatory processes. Its therapeutic indications in the EU include plaque psoriasis, psoriatic arthritis, axial spondyloarthritis, and hidradenitis suppurativa.

Safety information for BIMZELX®▼ (bimekizumab) in the EU/EEA includes common adverse reactions and contraindications, with careful monitoring advised for certain patient groups.

Healthcare professionals are encouraged to report any suspected adverse reactions, as this product is subject to additional monitoring for swift identification of new safety information.

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