SPEVIGO® 在美国获得突破性疗法认定，用于预防全身性脓疱性银屑病发作

Ingelheim, Germany – Boehringer Ingelheim today announced that spesolimab (marketed as SPEVIGO®) has been granted Breakthrough Therapy Designation (BTD) by the U.S. Food and Drug Administration (U.S. Food and Drug Administration) as an investigational treatment for the prevention of attacks of generalized pustular psoriasis (GPP) in adolescents and adults.

"GPP flares can appear suddenly, rapidly intensify, and if left untreated can be life-threatening, leaving affected people anxious and uncertain about their future," said Carinne Brouillon, Managing Director and Head of Human Pharmaceuticals at Boehringer Ingelheim. "The FDA's recognition of the urgent need to prevent GPP flares is an important step toward enabling people with this disease to plan for critical moments in their lives despite their disease."

The designation follows the China National Medical Products Administration (NMPA) Center for Drug Evaluation (CDE), which also recently granted spesolimab a BTD for the prevention of GPP flares.

The U.S. FDA and Chinese NMPA granted these designations based on primary results from the EFFISAYIL™ 2 trial, which investigated whether long-term treatment with the antibody spesolimab helps prevent the onset of GPP in adolescents and adults for up to 48 weeks. Safety data were consistent with previous clinical trials using spesolimab. Trial data will be presented at the 25th World Congress of Dermatology 2023 in early July.

About spesolimab

Spesolimab is a novel humanized selective antibody that blocks activation of the interleukin-36 receptor (IL-36R), a signaling pathway within the immune system that has been implicated in the pathogenesis of multiple autoinflammatory diseases, including GPP. Spesolimab has been approved by regulatory agencies in nearly 40 countries, including the United States, Japan, China and the European Union, for the treatment of GPP flares in adults.

It is the first approved GPP flare treatment specifically targeting the IL-36 pathway and has been evaluated in a statistically significant randomized placebo-controlled trial. 11 Spesolimab is also being investigated for the treatment of other IL-36-mediated dermatological disorders.

About the EFFISAYILTM Clinical Trial Program

The EFFISAYIL™ clinical trial program includes: EFFISAYIL™ 1: A Phase II study demonstrated that treatment of patients with GPP flares with a single intravenous dose of spesolimab resulted in rapid pustule and skin clearance lasting over 12 weeks. 11 These results support the approval of spesolimab (SPEVIGO®) as the first major market specialty treatment for GPP flare in adults.

EFFISAYIL™ 2: A multicenter, randomized, double-blind, placebo-controlled Phase IIb study evaluating the efficacy and safety of subcutaneous (SC) spesolimab maintenance therapy in preventing the onset of GPP and sustaining the control of GPP symptoms in adolescents and adults.

EFFISAYIL™ ON: An open-label extension study to evaluate the long-term safety and efficacy of spesolimab in GPP patients who have completed a previous spesolimab trial.