Spesolimab

Spesolimab, sold under the brand name Spevigo, is a monoclonal antibody medication used for the treatment of generalized pustular psoriasis (GPP).[3] It is an interleukin-36 receptor (IL1RL2/IL1RAP) antibody.[5]

Spesolimab
Monoclonal antibody
TypeWhole antibody
SourceHumanized
TargetInterleukin 36 receptor (IL1RL2/IL1RAP)
Clinical data
Trade namesSpevigo
Other namesBI-655130, spesolimab-sbzo
AHFS/Drugs.comMonograph
License data
Routes of
administration		Intravenous
ATC code
Legal status
Legal status
Identifiers
CAS Number
DrugBank
UNII
KEGG
Chemical and physical data
FormulaC6480H9988N1736O2012S46
Molar mass145880.08 g·mol−1

It was approved for medical use in the United States in September 2022,[6][7][8] and in European Union in December 2022.[4] The US Food and Drug Administration (FDA) considers it to be a first-in-class medication.[9]

Society and culture

On 13 October 2022, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion, recommending the granting of a conditional marketing authorization for the medicinal product Spevigo, intended for the treatment of flares in adult patients with generalised pustular psoriasis.[10] The applicant for this medicinal product is Boehringer Ingelheim International GmbH.[10] Spesolimab was approved for medical use in the European Union in December 2022.[4][11]

References
  1. "Summary Basis of Decision for Spevigo". Health Canada. 21 June 2023. Archived from the original on 20 August 2023. Retrieved 20 August 2023.
  2. "Details for: Spevigo". Health Canada. 11 May 2023. Archived from the original on 20 August 2023. Retrieved 20 August 2023.
  3. "Spevigo- spesolimab-sbzo injection". DailyMed. 1 September 2022. Archived from the original on 16 October 2022. Retrieved 16 October 2022.
  4. "Spevigo EPAR". European Medicines Agency (EMA). 12 October 2022. Archived from the original on 8 February 2023. Retrieved 8 February 2023. Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
  5. Ratnarajah K, Jfri A, Litvinov IV, Netchiporouk E (2020). "Spesolimab: A Novel Treatment for Pustular Psoriasis". Journal of Cutaneous Medicine and Surgery. 24 (2): 199–200. doi:10.1177/1203475419888862. PMID 32208020. S2CID 214641620.
  6. "Drug Approval Package: Spevigo". U.S. Food and Drug Administration (FDA). Archived from the original on 26 December 2022. Retrieved 2 September 2022.
  7. "U.S. FDA approves first treatment option for generalized pustular psoriasis flares in adults". Boehringer Ingelheim (Press release). Archived from the original on 2 September 2022. Retrieved 2 September 2022.
  8. "U.S. FDA approves first treatment option for generalized pustular psoriasis flares in adults" (Press release). Boehringer Ingelheim. 2 September 2022. Archived from the original on 2 September 2022. Retrieved 2 September 2022 – via Business Wire.
  9. "Advancing Health Through Innovation: New Drug Therapy Approvals 2022". U.S. Food and Drug Administration (FDA). 10 January 2023. Archived from the original on 21 January 2023. Retrieved 22 January 2023. Public Domain This article incorporates text from this source, which is in the public domain.
  10. "Spevigo: Pending EC decision". European Medicines Agency. 14 October 2022. Archived from the original on 15 October 2022. Retrieved 15 October 2022. Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
  11. "Spevigo Product information". Union Register of medicinal products. 12 December 2022. Archived from the original on 16 December 2022. Retrieved 3 March 2023.
  • "Spesolimab". Drug Information Portal. U.S. National Library of Medicine.


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