U.S. FDA Grants Breakthrough Therapy Designation to Spevigo for the prevention of GPP Flares

May 2, 2023
US FDA Grants Breakthrough Therapy Designation to Spevigo for the prevention of GPP Flares image

Boehringer Ingelheim's spesolimab has been approved by regulatory authorities in almost 40 countries to treat GPP flares in adults.

The U.S. Food and Drug Administration has granted Breakthrough Therapy Designation (BTD) to Spevigo for the prevention of generalized pustular psoriasis (GPP) flares, Boehringer Ingelheim reports.

This designation follows the Center for Drug Evaluation (CDE) of China National Medical Products Administration (NMPA), who also recently awarded spesolimab a BTD for the prevention of GPP flares. The FDA and China’s NMPA granted these designations based on the topline results from the EFFISAYIL 2 trial which studied whether long-term treatment with the antibody spesolimab helps prevent GPP flares in adolescents and adults with GPP up to 48 weeks. Safety data were in line with previously conducted clinical trials with spesolimab.

Spesolimab is a novel, humanized, 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 several autoinflammatory diseases, including GPP.

Spesolimab has been approved by regulatory authorities in almost 40 countries including the US, Japan, Mainland China, and the European Union to treat GPP flares in adults. It is the first approved treatment for GPP flares that specifically targets the IL-36 pathway. Spesolimab is also under investigation for the treatment of other IL-36 mediated skin diseases.

The EFFISAYIL clinical trial program 

EFFISAYIL 1 is a Phase II study that demonstrated treatment with a single intravenous dose of spesolimab achieved rapid pustular and skin clearance in patients with GPP flares, sustained over 12 weeks. These results supported the approval of spesolimab as the first specific treatment for GPP flares in adults in major markets.

EFFISAYIL 2 is a multicenter, randomized, double-blind, placebo-controlled Phase IIb study evaluating the efficacy and safety of maintenance treatment with subcutaneous (SC) spesolimab for the prevention of GPP flares and sustained control of GPP symptoms in adolescents and adults. Data from the trial will be presented at the 25th World Congress of Dermatology 2023 in early July.

EFFISAYIL ON is an open-label, extension study to evaluate the long-term safety and efficacy of spesolimab in patients with GPP, who have completed previous spesolimab trials

The U.S. Food and Drug Administration has granted Breakthrough Therapy Designation (BTD) to Spevigo for the prevention of generalized pustular psoriasis (GPP) flares, Boehringer Ingelheim reports.

This designation follows the Center for Drug Evaluation (CDE) of China National Medical Products Administration (NMPA), who also recently awarded spesolimab a BTD for the prevention of GPP flares. The FDA and China’s NMPA granted these designations based on the topline results from the EFFISAYIL 2 trial which studied whether long-term treatment with the antibody spesolimab helps prevent GPP flares in adolescents and adults with GPP up to 48 weeks.

Safety data were in line with previously conducted clinical trials with spesolimab.

Spesolimab is a novel, humanized, 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 several autoinflammatory diseases, including GPP.

Spesolimab has been approved by regulatory authorities in almost 40 countries including the US, Japan, Mainland China, and the European Union to treat GPP flares in adults. It is the first approved treatment for GPP flares that specifically targets the IL-36 pathway. Spesolimab is also under investigation for the treatment of other IL-36 mediated skin diseases.

The EFFISAYIL™ clinical trial program includes:

EFFISAYIL 1 is a Phase II study that demonstrated treatment with a single intravenous dose of spesolimab achieved rapid pustular and skin clearance in patients with GPP flares, sustained over 12 weeks. These results supported the approval of spesolimab as the first specific treatment for GPP flares in adults in major markets.

EFFISAYIL 2 is a multicenter, randomized, double-blind, placebo-controlled Phase IIb study evaluating the efficacy and safety of maintenance treatment with subcutaneous (SC) spesolimab for the prevention of GPP flares and sustained control of GPP symptoms in adolescents and adults. Data from the trial will be presented at the 25th World Congress of Dermatology 2023 in early July.

EFFISAYIL ON is an open-label, extension study to evaluate the long-term safety and efficacy of spesolimab in patients with GPP, who have completed previous spesolimab trials

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