New drug for psoriasis! Ukip's IL-17A/17F inhibitor bimekizumab is accepted by the US and Europe: better than Humira and Stelara!

September 24, 2020 // -- UCB recently announced that the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have accepted the biological product licensing application (BLA) and marketing authorization application (MAA) for the treatment of adult patients with moderate to severe plaque psoriasis, respectively.
bimekizumab is a unique molecule with a dual mechanism of action, a new type of humanized monoclonal IgG1 antibody that effectively and selectively neutralizes IL-17A and IL-17F, two key cytokines that drive the inflammatory process.
IL-17A and IL-17F have similar anti-inflammatory functions and work independently with other inflammatory media to drive chronic inflammation and damage in multiple tissues.
the unique IL-17A/IL-17F double inhibition of bimekizumab may provide a new targeted therapy for immunome-mediated inflammatory diseases.
preclinical studies in disease-related cells have shown that inhibiting IL-17F while suppressing IL-17F reduces skin and arthritis, as well as pathological bone formation, to a greater extent than inhibiting IL-17A alone.
currently, bimekizumab is being clinically developed in Phase III for the treatment of a variety of inflammatory diseases, including plaque-type psoriasis, psoriasis arthritis, mid-axis spinal arthritis, purulent sweat adenitis. "After a series of positive Phase 3 data readings, we are pleased to announce that the FDA and the European Union EMA have accepted our application to use bimekizumab as a potential new treatment for psoriasis," said Emmanuel Caeymaex, Executive Vice President and U.S. Director of
Excellent Immune Solutions.
this milestone brings us one step closer to being able to offer a meaningful new treatment option for people with this debilitating disease.
" bimekizumab regulatory filing, based on data from the Global Psoriasis Phase 3 Clinical Development Program.
All Phase 3 studies reached the primary endpoint and showed that patients treated with psoriasis area and severity index (PASI 90) and investigators' Global Assessment (IGA) dermal loss completely or almost completely cleared (IGA 0/1) were given better dermal removal at week 16 than patients receiving placebos and patients receiving Humira (Adamu monomatics).
3 studies reached the secondary end of the study.
two studies showed that at week 16, bimekizumab was superior to the existing biotherapy Stelara (Sidano ®, generic name: ustekinumab, Usnu monoanti, Johnson il-12/IL-23 inhibitors) and Humira (Adamo monoanti).
addition, bimekizumab is superior to placebo, Stelara, Humira in achieving rapid response (using the definition of PASI 75 in week 4).
in all studies, the clinical response lasted up to a year.
the safety of bimekizumab is consistent with earlier clinical studies and no new safety signals have been detected.
() Original origin: UCB Achieves Important Regulatory Milestone for Bimekizumab.