European Commission approval for 320 mg device presentations of Bimzelx (bimekizumab) – UCB

UCB, a global biopharmaceutical company, announced that the European Commission (EC) has granted marketing authorization for two 320 mg device presentations of Bimzelx (bimekizumab). The pre-filled syringe and pre-filled pen each contain 320 mg of bimekizumab in a volume of 2 mL and provide alternatives to the currently available 160 mg in a volume of 1 mL injection options.

“These single-injection options for bimekizumab strengthen and expand administration choices, aimed at enhancing the individual experience and offering increased convenience for patients requiring a 320 mg dose,” said Emmanuel Caeymaex, Executive Vice President, Head of Patient Impact, Chief Commercial Officer, UCB. “For example, with the 320 mg bimekizumab device options, patients with moderate to severe plaque psoriasis would receive six injections a year during maintenance dosing, which is one injection every eight weeks.”

The EC approval follows a positive opinion issued in May 2024 by the Committee for Medicinal Products for Human Use of the European Medicines Agency. The approval 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.

In the European Union, the indications for bimekizumab where a 320 mg dose is recommended are adults with moderate to severe plaque psoriasis, adults with active psoriatic arthritis with coexistent moderate to severe plaque psoriasis, and adults with active moderate to severe hidradenitis suppurativa.

Regulatory applications for the 320 mg bimekizumab in a volume of 2 mL device presentations are currently in review with the FDA and the Pharmaceuticals and Medical Devices Agency in Japan.