U.S. FDA grants priority review for spesolimab for the treatment of flares in patients with generalised pustular psoriasis, a rare, life-threatening skin disease

Boehringer Ingelheim

15 December 2021 - Additionally, FDA granted breakthrough therapy designation for spesolimab in the treatment of generalised pustular psoriasis flares.

Boehringer Ingelheim today announced that the U.S. FDA has accepted a biologics license application and granted priority review for spesolimab for the treatment of generalised pustular psoriasis flares.

Spesolimab is a novel, humanised, selective antibody that blocks the activation of the interleukin 36 receptor, a signalling pathway within the immune system shown to be involved in the pathogeneses of several autoimmune diseases, including generalised pustular psoriasis.

Read Boehringer Ingelheim press release

Michael Wonder

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Michael Wonder

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Medicine , US , Priority review , Dossier