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New IL-36 receptor monoclonal antibody takes a critical step in EU listing, and also submits marketing application in China

 Last Update: 2021-12-09
 Source: Internet
 Author: User

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On October 29th, Boehringer Ingelheim announced that the European Medicines Agency (EMA) has accepted an application for marketing authorization (MAA) for the interleukin-36 receptor (IL-36R) inhibitor spesolimab for treatment Onset of generalized pustular psoriasis (GPP)
.

Generalized pustular psoriasis is a rare, heterogeneous and potentially life-threatening neutrophilic skin disease
.

Different from psoriasis vulgaris, patients with non-acral skin will have widespread pus-filled blisters (pustules), and pain, and may be accompanied by systemic symptoms such as high fever, and can even cause life-threatening organ failure and infections.

IL-36 is a potent regulator of dendritic cells and T cells, and participates in the activation of dendritic cells and helper T cells, antigen presentation and stimulation of pro-inflammatory factor production
.

Studies have shown that IL-36 is abundantly expressed in the skin and plays an important role in the pathogenesis of psoriasis and other skin diseases

Spesolimab is a humanized monoclonal antibody targeting IL-36 receptor, which can block the effect of IL-36R.
It can treat skin diseases, palmoplantar pustulosis, ulcerative colitis and other inflammatory diseases.
Potential
.

In China, Boehringer Ingelheim also submitted a marketing application for a new immunological drug, spesolimab, to the Center for Drug Evaluation (CDE) of the China National Medical Products Administration for the treatment of the onset of generalized pustular psoriasis (GPP)

This application for marketing authorization is based on the positive results of a 12-week Phase 1 clinical trial
.

The trial evaluated the efficacy, safety, and tolerability of spesolimab.

Note: The original text has been deleted

Reference materials:

[1] Boehringer Ingelheim announces European Medicines Agency's filing acceptance and validation of marketing authorization application for spesolimab in generalized pustular psoriasis.

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