Boehringer Ingelheim's new immunotherapy drug spesolimab listed in priority review

On March 9, the Center for Drug Evaluation (CDE) of the State Drug Administration officially granted Boehringer Ingelheim the first-in-class immunology drug spesolimab (the company's own generic name: spesolimab injection) with priority review and approval Eligibility, the proposed indication is for the treatment of adults with generalized pustular psoriasis (GPP) episodes

Priority review is set up by the Center for Drug Evaluation (CDE) of the State Drug Administration to encourage the research and creation of new drugs, meet clinical drug needs, and speed up the review of innovative drugs

Unlike plaque psoriasis, GPP is a rare but more serious skin disease

In recent years, studies have found that pustular psoriasis is associated with the interleukin-36 (IL-36) pathway

About spesolimab

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

references:

[1] "Survey on the prevalence and disease burden of generalized pustular psoriasis in my country: an estimate based on the national urban medical insurance data from 2012 to 2016", the 27th National Dermatological Diseases of the Chinese Medical Association Academic Annual Meeting, June 2021

[2] Furue K, et al.

[3] Bachelez H, et al.

[4] ClinicalTrials.

[5] ClinicalTrials.

(Original abridged)