Johnson & Johnson has received FDA approval for Icotyde (icotrokinra), the first oral interleukin-23 (IL-23) receptor antagonist to treat moderate to severe psoriasis.
In four phase 3 trials, the drug had a favorable safety profile and met all of its primary efficacy endpoints, which included providing complete or almost complete skin clearance in 70% of patients. The once-daily pill will be available to adults and children aged 12 and above who weigh at least 40 kg.
"Icotyde delivers something unique in psoriasis treatment – combining skin clearance with a favorable safety profile in a once-daily pill, making it an easy addition to a patient's routine," said Linda Stein Gold, MD, Director of Dermatology Clinical Research at Henry Ford Health.
The drug originates from a deal between J&J and Protagonist Therapeutics inked in 2017. J&J signed a worldwide exclusive license and collaboration agreement to develop, manufacture, and commercialize what was then an IL-23R drug candidate for Crohn’s disease and ulcerative colitis.