FDA Accepts BLA for Bimekizumab for Plaque Psoriasis

The EMA has also accepted MMA for UCB's bimekizumab.

The FDA and the European Medicines Agency (EMA) have accepted the Biologics License Application (BLA) and Marketing Authorization Application (MAA), respectively, for bimekizumab for the treatment of adults with moderate to severe plaque psoriasis.

“After a series of positive Phase 3 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. 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,” says Emmanuel Caeymaex, Executive Vice President Immunology Solutions and Head of US, UCB.

The marketing application submissions for bimekizumab are based on data from a global Phase 3 clinical development program in psoriasis. All Phase 3 studies met their primary endpoints, demonstrating that bimekizumab-treated patients achieved superior skin clearance, at week 16, compared to those who received placebo and Humira (adalimumab) as measured by the Psoriasis Area and Severity Index (PASI 90) and an Investigator Global Assessment (IGA) response of clear or almost clear skin (IGA 0/1).

All the Phase 3 studies met their ranked secondary endpoints. Two studies demonstrated superior total skin clearance at week 16, as measured by PASI 100, confirming the superiority of bimekizumab over existing biologic treatments Stelara (ustekinumab) and adalimumab. Bimekizumab was superior to placebo, ustekinumab, and adalimumab in achieving rapid response, defined as PASI 75 at week 4. Clinical responses were maintained up to one year in all studies. The safety profile of bimekizumab continues to be consistent with earlier clinical studies with no new safety signals identified.