The US Food and Drug Administration (FDA) has approved UCB’s inflammatory disease drug to treat moderate-to-severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy.The decision makes Bimzelx (bimekizumab-bkzx) the first and only approved psoriasis treatment designed to selectively inhibit IL-17A and IL-17F, two key cytokines driving inflammatory processes.

More than 7.5 million adults in the US are affected by some form of psoriasis, a chronic inflammatory condition caused by dysfunction of the immune system, which results in skin cells reproducing at a faster rate than normal.Up to 90% of patients with psoriasis have plaque psoriasis, characterised by dry, raised, red skin lesions (plaques) covered with silvery scales. The plaques may be itchy or painful and can occur anywhere on the body, including the scalp, elbows, knees and lower back.

As well as its physical manifestations, psychological impact has been increasingly recognised as a significant part of the condition, with some patients also experiencing negative effects on their emotional well-being, physical activity, sleep quality, work and relationships.

“The approval of Bimzelx will provide an important new treatment option for adults living with moderate-to-severe-plaque psoriasis,” said Leah McCormick Howard, president and chief executive officer for the National Psoriasis Foundation. “Our hope is that new treatments translate into improved outcomes for many and help alleviate the physical and emotional burden of psoriasis.”

The FDA’s approval was supported by data from three late-stage trials in which patients treated with Bimzelx achieved superior levels of skin clearance after 16 weeks of treatment compared to those who received ustekinumab, placebo or adalimuma.More than 80% of patients receiving Bimzelx achieved clear or almost clear skin at week 16 and approximately 60% achieved complete skin clearance.

Clinical responses reached with Bimzelx at week 16 were also maintained for up to one year, UCB said, adding that long-term data showed that clinical responses were maintained in the vast majority of patients through three years of treatment.

Emmanuel Caeymaex, executive vice president, immunology solutions and head of US at UCB, said: “[The] FDA approval for Bimzelx is an exciting milestone that reflects our commitment to continuously improving the standard of care in plaque psoriasis and to raising expectations of what treatment can deliver.”Caeymaex added that the company will now “move forward rapidly” to submit applications for additional indications in the US, following the approval in psoriasis.

Source:

https://www.pmlive.com/pharma_news/fda_approves_ucbs_inflammatory_disease_drug_bimzelx_for_plaque_psoriasis_1502208