FDA and EMA accept regulatory submissions for UCB’s bimekizumab

The US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have both accepted marketing application submissions for UCB’s psoriasis treatment bimekizumab.

UCB is seeking approval for bimekizumab in both the US and EU for the treatment of moderate-to-severe plaque psoriasis in adults.

Both marketing applications are based on a data package from UCB’s global phase III clinical development programme in psoriasis. All phase III studies met their primary endpoints, demonstrating that bimekizumab-treated patients achieved superior skin clearance at week 16 compared to those who received placebo and AbbVie’s Humira (adalimumab).

In addition, UCB’s treatment met all secondary endpoints in the same trials, with two of the studies demonstrating superior total skin clearance at week 16, confirming the superiority of bimekizumab over existing biologic treatments including Janssen’s Stelara (ustekinumab) and Humira.

As well as being studied as a treatment for psoriasis, bimekizumab is currently being investigated as a potential therapy for psoriatic arthritis, ankylosing spondylitis, non-radiographic axial spondyloarthritis and hidradenitis suppurativa.

“After a series of positive phase III data readouts, we are delighted to announce that the US FDA and EMA have accepted our applications to file bimekizumab as a potential new treatment for psoriasis,” said Emmanuel Caeymaex, executive vice president Immunology Solutions and head of US, UCB.

This milestone brings us one step closer to being able to offer a meaningful new treatment option for people living with this debilitating disease. UCB is committed to providing innovative solutions for people living with serious inflammatory diseases like psoriasis,” he added.