Boehringer Ingelheim announced that the European Medicines Agency has accepted and reviewed the marketing authorization application for spesolimab for the treatment of generalized pustular psoriasis

Ingelheim, Germany, November 2, 2021/PRNewswire/ - Boehringer Ingelheim announced today that its new drug marketing authorization application (MAA) for the treatment of generalized pustular psoriasis (GPP) has been accepted.
It is currently being reviewed by the European Medicines Agency (EMA)
.

"GPP is a rare and life-threatening neutrophil skin disease characterized by the sudden appearance of sterile, pus-filled blisters and painful sensations all over the body," said Janine, Boehringer Ingelheim Global Head of Spesolimab Lamar said
.

"Although it is called psoriasis, GPP is very different from the common plaque psoriasis

The characteristic of GPP is the widespread appearance of painful, sterile pustules (non-infectious pustules) on the body
.

[1],[2],[3] Inflammation can also affect other parts of the body and may cause infection or other organ complications that may be life-threatening

Patients with GPP urgently need therapies that can quickly resolve the symptoms of acute attacks
.

The onset of the disease greatly affects the patient's quality of life, and may lead to hospitalization and life-threatening complications, such as heart failure, kidney failure, sepsis and even death

About Spesolimab

Spesolimab is a new humanized selective antibody that blocks the activation of interleukin-36 receptor (IL-36R)
.

The IL-36 pathway is a signaling pathway in the immune system, which has been shown to be related to the etiology of many autoimmune diseases such as GPP

About generalized pustular psoriasis

GPP is a rare, heterogeneous, and life-threatening neutrophilic skin disease, which is clinically different from plaque psoriasis
.

[1], [2] GPP is caused by the accumulation of neutrophils (a type of white blood cell) in the skin, which can cause painful sterile pustules

GPP treatment

Patients with GPP are in urgent need of treatments that can quickly resolve the symptoms of acute attacks, prevent recurrence of the disease, and have acceptable safety
.

Based on the clinical experience of treating patients with plaque psoriasis, immunomodulatory therapies (including biological agents) are used to treat GPP

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.

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[2] Navarini AA, et al.
European consensus statement on phenotypes of pustular psoriasis.
JEADV.
2017;31:1792-1799.

[3] Fujita H, et al.
Japanese guidelines for the management and treatment of generalized pustular psoriasis: The new pathogenesis and treatment of GPP.
J Dermatol.
2018;45(11):1235–1270.

[4] Furue K, et al.
Highlighting Interleukin-36 Signalling in Plaque Psoriasis and Pustular Psoriasis.
Acta Derm Venereol.
2018;98:5–13.

[5] Bachelez H, et al.
Inhibition of the Interleukin-36 Pathway for the Treatment of Generalized Pustular Psoriasis.
N Engl J Med.
2019; 380:981-983.

[6] ClinicalTrials.
gov.
A Study to Test Whether Spesolimab Helps People With a Skin Disease Called Hidradenitis Suppurativa.
Available at: https://clinicaltrials.
gov/ct2/show/NCT04762277.
Accessed October 2021.

[7] ClinicalTrials.
gov.
A Study to Test Long-term Treatment With Spesolimab in People With Palmoplantar Pustulosis (PPP) Who Took Part in Previous Studies With Spesolimab.
Available at https://clinicaltrials.
gov/ct2/show/NCT04493424.
Accessed: October 2021.

[8] Ohkawara A et al.
Generalized pustular psoriasis in Japan: two distinct groups formed by differences in symptoms and genetic background.
Acta Derm Venereol.
1996 Jan;76(1):68–71.

[9] Augey F, et al.
Generalized pustular psoriasis (Zumbusch): a French epidemiological survey.
European Journal of Dermatology.
2006; 16(6):669-673.

[10] Jin H, et al.
Clinical features and course of generalized pustular psoriasis in Korea.
The Journal of Dermatology.
2015; 42(7):674-678.

Source: Boehringer Ingelheim