FDA accepts spesolimab for priority review in GPP

The US Food and Drug Administration has accepted a Biologics License Application (BLA) and granted Priority Review for spesolimab for the treatment of generalized pustular psoriasis (GPP) flares, that was submitted by German family-owned pharma major Boehringer Ingelheim.

FDA grants Priority Review to applications for medicines that, if approved, would offer significant improvement over available options in the safety or effectiveness of the treatment, diagnosis, or prevention of serious conditions. The FDA has granted spesolimab Orphan Drug designation for the treatment of GPP, and Breakthrough Therapy designation for spesolimab for the treatment of GPP flares in adults.

"The FDA acceptance of our filing for spesolimab is a critical step in our efforts to bring this first-in-class treatment to people living with GPP," said Dr Matt Frankel, vice president, clinical development and medical affairs, Specialty Care, Boehringer Ingelheim. “There is an urgent unmet need for an approved treatment option that can rapidly clear painful GPP flares," he noted.