UCB has clinical data showing its plaque psoriasis drug works better at clearing skin compared to a blockbuster product from Johnson & Johnson, but the Belgian pharmaceutical company won’t be able to bring its biological medicine to U.S. patients anytime soon. The FDA rejected UCB’s drug application, citing inspection issues with a manufacturing site.
The complete response letter to the company is the latest delay for the drug, bimekizumab. Last October, the FDA deferred a regulatory decision on the drug, citing the need to conduct on-site inspections of the European facilities where the product will be manufactured. According to UCB, the FDA said Covid-19 travel restrictions prevented the agency from conducting the inspections. It’s the same issue that has come up in the review of many drug applications in the past two years, particularly for biological products. No issues about bimekizumab’s safety or efficacy were raised, nor did the FDA ask the company to conduct another clinical trial.
UCB said Friday that the FDA’s complete response letter stated that certain pre-approval inspection observations must be resolved before bimekizumab’s application can be approved. The company did not specify what those remaining issues are, but it said that it is cooperating with the agency and “working to address these observations as expeditiously as possible.”
Psoriasis is an inflammatory disorder that leads to red patches of skin and dry, cracked skin that may bleed. Plaque psoriasis is the most common form of psoriasis, presenting as darker and thicker patches on the skin that may also be itchy and painful.
Bimekizumab is an antibody designed to selectively block IL-17A and IL-17F, two cell signaling proteins that drive the inflammation behind psoriasis. J&J’s Stelara is also an antibody, but that drug is designed to block two other signaling proteins: IL-12 and IL-23. It won its first approval in 2009 for treating adults with moderate-to-severe plaque psoriasis. The drug also has approvals in psoriatic arthritis and Crohn’s disease. In 2021, the drug generated more than $9.1 billion in worldwide revenue, an 18.5% increase over the prior year, according to J&J’s financial reports.
During the 2020 annual meeting of the American Academy of Dermatology, UCB presented Phase 3 data showing that patients treated with bimekizumab had better skin clearance compared to those who received either a placebo or Stelara. Most of the those treated with the UCB drug achieved total skin clearance after 16 weeks and maintained this clearance for one year.
Bimekizumab is already competing head to head against Stelara in other markets around the world. Last August, the drug was granted marketing authorization in the European Economic Area and Great Britain as a treatment for moderate-to-severe plaque psoriasis in adults. In January, regulators in Japan approved the drug for treating plaque psoriasis, generalized pustular psoriasis, and psoriatic erythroderma in patients who do not sufficiently respond to earlier lines of treatment. Canada approved the UCB drug in February, followed by a regulatory nod in Australia in March.
Public domain image by the Centers for Disease Control and Prevention