Boehringer Ingelheim has announced acceptance of a biologics license application (BLA) and granting of priority review by the US Food and Drug Administration (FDA) for spesolimab in treating generalized pustular psoriasis (GPP) flares.
The drug regulatory agency granted orphan drug designation to spesolimab for GPP treatment, and breakthrough therapy designation to treat GPP flares in adults.
Boehringer Ingelheim vice president for clinical development and medical affairs, specialty care Matt Frankel said: “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.
“There is an urgent unmet need for an approved treatment option that can rapidly clear painful GPP flares.”
A rare, life-threatening neutrophilic skin disease, GPP is different from plaque psoriasis.
It is marked by events of widespread eruptions of painful, sterile pustules.
Currently, there is a great unmet requirement for therapies to quickly and fully treat the signs and symptoms of GPP flares.
Flares can impact a person’s life, and also lead to hospitalization with serious complications, such as renal failure, sepsis, heart failure, and even death.
A humanized, selective antibody, spesolimab hinders the activation of the interleukin-36 receptor (IL-36R) that is considered a signaling pathway within the immune system involved in the pathogeneses of many autoimmune diseases, including GPP.