UCB’s long-awaited FDA approval for its psoriasis therapy, Bimzelx (bimekizumab), has finally arrived, ending a journey marked by manufacturing setbacks. The significance of this milestone cannot be understated.
Bimzelx stands out as a pioneering psoriasis treatment, working by selectively inhibiting interleukin 17A (IL-17A) and interleukin 17F (IL-17F), two pivotal cytokines intricately involved in the inflammatory processes underlying psoriasis, according to a statement from UCB. The green light from the FDA extends to the treatment of moderate-to-severe plaque psoriasis in adults eligible for systemic therapy or phototherapy.
The drug’s efficacy was rigorously validated in phase 3 trials, where Bimzelx consistently outperformed the placebo and well-established psoriasis medications such as AbbVie’s Humira and Johnson & Johnson’s Stelara. Notably, in these trials, 85% to 91% of patients treated with Bimzelx achieved clear or nearly clear skin by the 16th week, as assessed by the Psoriasis Area & Severity Index (PASI) or investigator evaluation. Furthermore, between 59% to 68% of patients across these studies experienced complete skin clearance (PASI 100) by the 16th week.
The journey to FDA approval, however, was marked by regulatory hurdles. Initially, the FDA postponed its decision in October 2021 due to COVID-related travel restrictions preventing an inspection at UCB’s Belgian manufacturing facility. After the FDA’s visit in 2022, a complete response letter was issued in May 2022. The inspection was revisited in April 2023 following UCB’s resubmission, finally culminating in a positive outcome last month.
This FDA nod represents just the initial chapter for Bimzelx. UCB is now gearing up for a swift expansion, intending to pursue additional indications for the drug. According to Emmanuel Caeymaex, UCB’s Executive Vice President of Immunology Solutions and Head of UCB’s US business, the company will target diseases for which the drug is already approved overseas, including generalized pustular psoriasis, non-radiographic axial spondyloarthritis, and psoriatic arthritis.
The delay in approval turned into an advantage, allowing UCB to amass the requisite data for these additional indications. CEO Jean-Christophe Tellier emphasized that Bimzelx holds a “best-in-disease” profile for both psoriasis and psoriatic arthritis, offering a compelling value proposition.
Also Read: UCB’s Psoriasis Drug Application Overcomes Manufacturing Hurdle But Hits Another FDA Delay
UCB has set its sights high, with expectations that the drug’s global peak sales will reach at least 4 billion euros. Bimzelx has already made its debut in Europe, Japan, the UK, and other nations, generating 52 million euros in revenue during the first half of 2023. The medication is poised to enter the US market in approximately one month.
This significant development positions Bimzelx as a game-changer in the treatment of psoriasis, with broader horizons on the horizon and immense growth potential.
