UCB's bimekizumab, after FDA rejection in psoriasis, proves its worth in hidradenitis suppurativa

After UCB’s highly anticipated psoriasis drug bimekizumab hit an FDA wall due to facility inspection issues, the company is touting its promise in a new use.

Friday, the Belgian drugmaker said its medicine delivered "statistically significant and consistent clinically meaningful improvements" over placebo in two phase 3 trials in hidradenitis suppurativa.

The trials, dubbed BE HEARD I and BE HEARD II, enrolled 505 patients and 509 patients, respectively. At Week 16, the UCB drug delivered an improvement over placebo in the percentage of patients who achieved a 50% reduction in skin abscesses and inflammatory nodules from baseline. The trials therefore met their primary endpoints.

UCB plans to start global filings based on the results in the third quarter of 2023.

Hidradenitis suppurativa is a chronic and debilitating inflammatory skin disease characterized by abscesses, nodules and pus-discharging fistulas that flare up in the armpit, groin and buttock areas. It develops in early adulthood and affects approximately 1% of the population in most studied countries.

In a prior phase 3 trial, UCB's drug beat Johnson & Johnson’s psoriasis superstar Stelara in that lucrative use, prompting big commercial expectations among market watchers.

While the drug couldn’t make it past the FDA on its first attempt thanks to issues with the agency’s facility inspections, bimekizumab won a European approval in psoriasis last August. Other approvals followed in Great Britain, Japan, Canada and Australia.

In hidradenitis suppurativa, AbbVie’s top seller Humira is currently the only approved drug to treat the condition.

But more competition could be on the horizon. Novartis’ blockbuster Cosentyx also proved its worth in clinical testing, providing rapid and sustained relief to patients in two phase 3 trials. Those data were presented at the 31st European Academy of Dermatology and Venereology Congress in September. At the time, Novartis said it submitted its data to EU regulators and planned to file in the U.S. by the end of this year.