FDA Sets PDUFA Action Date for UCB’s Bimekizumab

The FDA has set a PDUFA action date of Oct. 15 for UCB’s investigational drug, bimekizumab, a treatment for moderate-to-severe plaque psoriasis that could mean more competition for AbbVie’s blockbuster immunosuppressive drug Humira.

The monoclonal antibody works by selectively inhibiting two cytokines, interleukin-17A and interleukin-17F, that cause skin inflammation.

In a phase 3 study, the drug demonstrated higher skin clearance rates vs. Humira (adalimumab) in adult patients with moderate-to-severe plaque psoriasis, UBC said. Humira earned $19.8 billion in 2020.

The Belgian drugmaker is hoping to begin marketing bimekizumab in the U.S. later this year. The drug is also under review by regulators in the EU, Japan, Australia and Canada.