Boehringer Ingelheim's spesolimab receives US FDA approval for generalized pustular psoriasis flares in adults

Boehringer Ingelheim have announced that the U.S. Food and Drug Administration have approved spesolimab as a treatment option for generalized pustular psoriasis (GPP) flares in adults.

Spesolimab, marketed in the U.S. as SPEVIGO, is a novel, selective antibody that blocks the activation of the interleukin-36 receptor (IL-36R), a signaling pathway within the immune system shown to be involved in the pathogenesis of GPP.

The FDA’s approval of spesolimab is based on results from the pivotal EFFISAYIL 1 Phase II clinical trial. In the 12-week trial, patients experiencing a GPP flare were treated with spesolimab or placebo. Most patients at the outset of the trial had a high, or very high, density of pustules, and impaired quality of life. After one week, 54% of patients treated with spesolimab showed no visible pustules compared to placebo (6%).1

In addition to the U.S. approval, spesolimab is currently under review by several other regulatory authorities. To date, spesolimab has received Breakthrough Therapy Designation in the U.S., China and Taiwan, Priority Review in the U.S. and China, Orphan Drug Designation in the U.S., Korea, Switzerland and Australia, Rare Disease Designation and fast track in Taiwan, for the treatment of GPP flares. The European Medicines Agency validated the marketing authorization application for spesolimab in GPP in October 2021 and the submission is currently under evaluation.

OMBLASTYS (omburtamab) goes to ODAC on October 28 2022

Y-mAbs Therapeutics, Inc. (Nasdaq: YMAB), a commercial-stage biopharmaceutical company focused on the development and commercialization of novel, antibody-based therapeutic products for the treatment of cancer, have announced that a meeting of the Oncologic Drugs Advisory Committee (ODAC) of the U.S. Food and Drug Administration (FDA) has been scheduled for October 28, 2022 to review the Company’s Biological License Application (BLA) for its product candidate, OMBLASTYS (omburtamab), an investigational radiolabeled antibody construct. 

Y-mAbs resubmitted the BLA for OMBLASTYS on March 31, 2022, and the FDA assigned a Prescription Drug User Fee Act goal date of November 30, 2022, for the completion of its priority review of the OMBLASTYS BLA.