MedPath

Spesolimab

Generic Name
Spesolimab
Brand Names
Spevigo
Drug Type
Biotech
CAS Number
2097104-58-8
Unique Ingredient Identifier
5IB2J79MCX
Background

Spesolimab is an interleukin-36 (IL-36) receptor antagonist. It is a humanized monoclonal immunoglobulin G1 antibody that was produced in Chinese hamster ovary (CHO) cells by recombinant DNA technology. The biosimilar of the drug, spesolimab-sbzo, was first approved by the FDA in September 2022 to treat generalized pustular psoriasis flares. Spesolimab works by inhibiting the inflammatory signaling pathway of IL-36, which is often overexpressed and aberrantly overactive in generalized pustular psoriasis. Spesolimab received recommendations from the EMA's Committee for Medicinal Products for Human Use (CHMP) to be granted marketing authorization in October 2022 and was finally approved in December 2022 for the treatment of flares in adult patients with generalized pustular psoriasis.

Indication

Spesolimab is indicated for the treatment of generalized pustular psoriasis (GPP) flares in adults.

Associated Conditions
Generalized Pustular Psoriasis (GPP)
Associated Therapies
Monotherapy

CDMO Market Report: Key Regulatory Approvals and Clinical Advances in March-April 2025

• Multiple CDMOs secured significant contract manufacturing opportunities as regulatory bodies approved new indications for established drugs, particularly in oncology and rare diseases. • AstraZeneca's portfolio saw substantial growth with expanded approvals for Imfinzi, Tagrisso, and Lynparza, strengthening partnerships with contract manufacturers including Lonza, Dottikon, and Samsung Biologics. • Contract manufacturers supporting treatments for autoimmune conditions showed strong performance, with Argenx's Vyvgart Hytrulo receiving expanded indications for myasthenia gravis and CIDP.

Scotland Approves New Cancer Treatments for Prostate and Liver Cancers

• The Scottish Medicines Consortium (SMC) has approved talazoparib (Talzenna) in combination with enzalutamide for treating adults with prostate cancer, offering a targeted oral therapy option. • Cabozantinib (Cabozantinib Ipsen) has been accepted for treating adults with hepatocellular carcinoma (HCC) who have received previous treatment, expanding options for liver cancer patients. • The SMC rejected two other medications: ripretinib (Qinlock) for gastrointestinal stromal tumors and spesolimab (Spevigo) for generalised pustular psoriasis, citing cost-effectiveness and evidence uncertainties.

FDA Approves Spevigo: First-Ever Treatment for Generalized Pustular Psoriasis Flares

Boehringer Ingelheim's spesolimab (Spevigo) has received FDA approval as the first dedicated treatment for generalized pustular psoriasis (GPP) flares. In the pivotal EFFISAYIL 1 trial, 54% of patients treated with spesolimab showed complete clearance of pustules within one week, marking a significant advancement in the management of this rare, life-threatening skin condition.
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