Spesolimab

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
Pregnancy
category
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

Spesolimab, sold under the brand name Spevigo, is a monoclonal antibody used for the treatment of generalized pustular psoriasis (GPP).[4] It is an interleukin-36 receptor (IL-36R) antagonist.[4][6] It is given via injection into a vein.[4][6]

The most common adverse reactions include fatigue, nausea and vomiting, headache, pruritus (itching) and prurigo (itchy bumps), bruising, and urinary tract infection.[4][6]

It was approved for medical use in the United States in September 2022,[7][8][9][10] and in European Union in December 2022.[5] The US Food and Drug Administration (FDA) considers it to be a first-in-class medication.[11][12]

  1. ^ a b "Spevigo APMDS". Therapeutic Goods Administration (TGA). 8 December 2023. Archived from the original on 2 January 2024. Retrieved 7 March 2024.
  2. ^ "Summary Basis of Decision for Spevigo". Health Canada. 21 June 2023. Archived from the original on 20 August 2023. Retrieved 20 August 2023.
  3. ^ "Details for: Spevigo". Health Canada. 11 May 2023. Archived from the original on 20 August 2023. Retrieved 20 August 2023.
  4. ^ a b c d e "Spevigo- spesolimab-sbzo injection". DailyMed. 1 September 2022. Archived from the original on 16 October 2022. Retrieved 16 October 2022.
  5. ^ a b Cite error: The named reference Spevigo EPAR was invoked but never defined (see the help page).
  6. ^ a b c Cite error: The named reference Spevigo FDA snapshot was invoked but never defined (see the help page).
  7. ^ "Drug Approval Package: Spevigo". U.S. Food and Drug Administration (FDA). Archived from the original on 26 December 2022. Retrieved 2 September 2022.
  8. ^ "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.
  9. ^ "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.
  10. ^ Blair HA (November 2022). "Spesolimab: First Approval". Drugs. 82 (17): 1681–1686. doi:10.1007/s40265-022-01801-4. PMC 9744699. PMID 36418672.
  11. ^ "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.
  12. ^ New Drug Therapy Approvals 2022 (PDF). U.S. Food and Drug Administration (FDA) (Report). January 2024. Archived from the original on 14 January 2024. Retrieved 14 January 2024. Public Domain This article incorporates text from this source, which is in the public domain.