UCB’s clinical data shows its plaque psoriasis drug is better at clearing skin than Johnson & Johnson’s blockbuster, but the Belgian drugmaker won’t be able to bring its biologic to U.S. patients anytime soon .U.S. Food and Drug Administration be rejected UCB’s drug application cites inspection issues at the manufacturing site.
The full response letter to the company is the latest delay in the drug, bimekizumab. In October last year, the FDA postpone The regulatory decision on the drug was citing the need for on-site inspections of European facilities where the product will be manufactured. According to UCB, the FDA said Covid-19 travel restrictions prevented the agency from conducting inspections. The same question has arisen in the review of many drug applications over the past two years, especially biologics. No questions were raised about the safety or efficacy of bimekizumab, and the FDA has not asked the company to conduct another clinical trial.
The FDA’s full response letter said certain pre-approval inspection observations must be addressed before the bimekizumab application can be approved, UCB said Friday. The company didn’t specify what the remaining issues were, but it said it was working with the agency and “working to resolve these observations as quickly as possible.”
Psoriasis is an inflammatory disease that causes red patches on the skin and dry, cracked skin that may bleed. Plaque psoriasis, the most common form of psoriasis, appears as darker and thicker patches on the skin that can also be itchy and painful.
Bimekizumab is an antibody designed to selectively block IL-17A and IL-17F, two cell signaling proteins that drive inflammation in psoriasis. Johnson & Johnson’s Stelara is also an antibody, but the drug is designed to block two other signaling proteins: IL-12 and IL-23. It was first approved in 2009 for the treatment of adults with moderate to severe plaque psoriasis. The drug is also approved for psoriatic arthritis and Crohn’s disease. In 2021, the drug generated more than $9.1 billion in global revenue, up 18.5% from the previous year, according to J&J’s financial report.
At the 2020 Annual Meeting of the American Academy of Dermatology, UCB provided data for Phase 3 showed better skin clearance in patients treated with bimekizumab compared to patients receiving placebo or Stelara. Most patients treated with UCB drugs achieved complete skin clearance after 16 weeks and maintained clearance for one year.
Bimekizumab is already competing head-to-head with Stelara in other markets around the world. Last August, the drug received marketing authorization in the European Economic Area and the United Kingdom for the treatment of adults with moderate-to-severe plaque psoriasis. In January, Japanese regulators approved the drug for plaque psoriasis, generalized pustular psoriasis and psoriatic erythroderma in patients who do not respond adequately to earlier treatment regimens. Canada approved the UCB drug in February, followed by regulatory approval in Australia in March.
Public area picture Centers for Disease Control and Prevention
