FDA accepts supplemental BLAs for Bimzelx for hidradenitis suppurativa, 2 mL device

Key takeaways:

• Data from the phase 3 BE HEARD trials contributed to the sBLA acceptance.
• Patients in the trials had significant improvement in HS signs and symptoms compared with placebo.

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, UCB announced in a press release.

Bimzelx (bimekizumab-bkzx), a monoclonal iGG1 antibody designed to inhibit interleukins 17A and 17F, is currently approved by the FDA for the treatment of moderate to severe plaque psoriasis.

Data from the phase 3 BE HEARD I and BE HEARD II trials contributed to the acceptance of the supplemental biologics license application (sBLA) for HS.

In the two multicenter, randomized, double-blind, placebo-controlled studies, a statistically significant number of patients achieved at least a 50% or 75% improvement from baseline in Hidradenitis Suppurativa Clinical Response compared with placebo at week 16.

“We are excited to share the progress on our FDA applications. The most recent sBLA seeks approval for bimekizumab-bkzx in moderate to severe hidradenitis suppurativa, and is aligned to our goal of expanding the reach of bimekizumab to more patients living with IL-17-mediated diseases,” Emmanuel Caeymaex, executive vice president of immunology solutions and head of U.S. at UCB, said in the release.

An additional sBLA was accepted for a 2 mL safety syringe and autoinjector for Bimzelx. Currently, a single dose of bimekizumab for moderate to severe plaque psoriasis is given via two 1 mL injections.

“Approval of the 2 mL device presentations would mean that patients would have an alternative one injection regimen option,” Caeymaex said.

Previous sBLAs for Bimzelx have been accepted for the treatment of psoriatic arthritis, non-radiographic axial spondylarthritis and ankylosing spondylitis.