On May 2, Boehringer Ingelheim announced that spesolimab, an antibody that blocks activation of the IL-36 receptor, received Breakthrough Therapy designation from the U.S. Food and Drug Administration as well as Breakthrough Therapy designation from the Center for Drug Evaluation of the China National Medical Products Administration to prevent flares of generalized pustular psoriasis in adolescent and adult patients. The designations were based on results from the EFFISAYIL 2 trial, which, according to a report from Boehringer Ingelheim issued in April, met its primary endpoint—time to first generalized pustular psoriasis flare-up to week 48—and a key secondary endpoint, the occurrence of at least one flare-up to week 48. More data from the trial will be presented at the upcoming 25th World Congress of Dermatology Singapore 2023, taking place from July 3 to 8 in Suntec City.
May 25, 2023