FDA approval for 320 mg single-injection device presentations of Bimzelx – UCB

UCB  announced that the FDA has approved a 2 mL pre-filled syringe and pre-filled autoinjector, each containing 320 mg of Bimzelx (bimekizumab-bkzx). These new device presentations add to the currently available 1 mL administration options, each containing 160 mg of bimekizumab-bkzx, and mean that patients requiring a 320 mg dose of bimekizumab-bkzx will have options for single-injection administration. “Our goal with these single-injection regimens is to strengthen and expand administration options, increase convenience and enhance the individual patient experience,” said Emmanuel Caeymaex, Executive Vice President, Head of Patient Impact, Chief Commercial Officer, UCB. “With the new device presentations, people with moderate-to-severe plaque psoriasis who receive a bimekizumab-bkzx maintenance dose of 320 mg will have the option of a single-injection every eight weeks.”

The approval of the 320 mg device presentations is supported by data from studies evaluating the bioequivalence of bimekizumab-bkzx 320 mg given as one 2 mL subcutaneous injection, and bimekizumab-bkzx 320 mg given as two 1 mL subcutaneous injections, in healthy study participants. This is the second worldwide approval for the 320 mg single-injection administration options for bimekizumab-bkzx, following approval by the European Commission in August 2024.

In the U.S., the indications for bimekizumab-bkzx where a 320 mg dose is recommended are adults with moderate-to-severe plaque psoriasis and adults with active psoriatic arthritis with coexistent moderate-to-severe plaque psoriasis. In all other indications, adults with active psoriatic arthritis, adults with active non-radiographic axial spondyloarthritis with objective signs of inflammation, and adults with active ankylosing spondylitis, a 160 mg dose is recommended.

In October 2023, bimekizumab-bkzx was first approved by the  FDA for the treatment of moderate-to-severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy. In September 2024, bimekizumab-bkzx was approved in the U.S. for three new indications – the treatment of adults with active psoriatic arthritis, adults with active non-radiographic axial spondyloarthritis with objective signs of inflammation and adults with active ankylosing spondylitis.

These new device presentations will be available in the U.S. in Q1 2025.

*The recommended dosage of bimekizumab-bkzx in patients with plaque psoriasis and patients with psoriatic arthritis with coexistent moderate-to-severe plaque psoriasis is 320 mg at Weeks 0, 4, 8, 12, and 16, then every 8 weeks thereafter. For patients weighing 120 kg or more, consider a dosage of 320 mg every 4 weeks after Week 16.