CHMP positive opinion for two 320 mg device presentations of Bimzelx (bimekizumab) – UCB

UCB, announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending granting marketing authorization for two new device presentations of bimekizumab, a pre-filled syringe and a pre-filled pen, each containing 320 mg in a volume of 2 mL.

“UCB developed these new device presentations to enhance the individual patient experience. If approved, these new options would allow for a single injection of a 320 mg dose of bimekizumab, simplifying administration and providing increased convenience for patients,” said Emmanuel Caeymaex, Executive Vice President, Head of Patient Impact, Chief Commercial Officer, UCB.

In the European Union (EU), bimekizumab is currently approved as a 160 mg solution for injection in pre-filled syringe and a 160 mg solution for injection in a pre-filled pen, each with a total volume of 1 mL. In the EU, the recommended dose of bimekizumab for the treatment of moderate to severe plaque psoriasis or active moderate to severe hidradenitis suppurativa is 320 mg, which is administered as two 1 mL injections. If approved by the European Commission (EC), the new device presentations would provide additional options for single-injection administration of 320 mg bimekizumab in a volume of 2 mL.

The CHMP positive opinion is based on data from studies evaluating the bioequivalence of bimekizumab 320 mg given as one 2mL subcutaneous injection, and bimekizumab 320 mg given as two 1mL subcutaneous injections, in healthy study participants. The CHMP’s recommendation will now be reviewed by the EC for marketing authorization in the European Union, as well as countries of the European Economic Area. A final decision is expected within approximately two months.