EU approves 320 mg Bimzelx, 2 mL devices for multiple inflammatory diseases

Key takeaways:

• Bimzelx is now approved in the EU for 320 mg administered in a 2 mL pre-filled syringe and 2 mL pre-filled pen.
• Applications of Bimzelx are still under review by regulatory authorities in the U.S. and Japan.

The European Commission has granted marketing authorization for two devices that administer Bimzelx for the treatment of multiple inflammatory diseases, UCB announced in a press release.

Bimzelx (bimekizumab, UCB) is a humanized monoclonal IgG1 antibody and interleukin 17A and 17F inhibitor that is currently indicated in the EU for plaque psoriasis, psoriatic arthritis, axil spondylarthritis and hidradenitis suppurativa.

Previously available in only 160 mg doses in a volume of 1 mL pre-filled syringe injections, the drug is now also approved in the EU for 320 mg in a volume of 2 mL in both a pre-filled syringe and pre-filled pen.

“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,” Emmanuel Caeymaex, executive vice president of immunology solutions and head of U.S. at UCB, said in the release. “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.”

According to the press release, the 320 mg dosage, as opposed to the 160 mg dosage, is recommended for the treatment of moderate to severe or active disease.

As Healio previously reported, supplemental biologics license applications for Bimzelx for the treatment of hidradenitis suppurativa and a 2 mL autoinjector device for the drug have been accepted by the FDA and are currently under review in the U.S. and Japan.