Chemistry:Spesolimab

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Short description: Monoclonal antibody
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]

Medical uses

Spesolimab is indicated for the treatment of generalized pustular psoriasis flares in adults.[4][6]

History

The US Food and Drug Administration (FDA) approved spesolimab based on evidence from a clinical trial of 53 adults with generalized pustular psoriasis flare.[6] The trial was conducted at three sites in the United States and 23 sites globally (Africa, Asia, and Europe).[6] Spesolimab was evaluated in one clinical trial (Study Effisayil-1/NCT03782792) of 53 adults with generalized pustular psoriasis flare.[6] In the trial, participants received a single treatment with either spesolimab or placebo.[6] Participants were evaluated for clearance of pustules based on a Generalized Pustular Psoriasis Physician Global Assessment (GPPPGA) pustulation sub score of 0 (indicating no visible pustules) at Week 1.[6] Neither the participant nor the healthcare providers knew which treatment was being given until after week 1.[6] After week 1, all participants, whether they initially received spesolimab or placebo, who continued to experience flare symptoms, had the option to receive a single open-label treatment of spesolimab (second treatment and first treatment for participants in the spesolimab and placebo groups, respectively).[6] After week 1 to week 12, participants in either original treatment group whose generalized pustular psoriasis flare reoccurred after achieving a clinical response were eligible to receive a single open-label rescue treatment of spesolimab, with a maximum of three total treatments of spesolimab throughout the trial.[6]

Society and culture

Legal status

In 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.[13] The applicant for this medicinal product is Boehringer Ingelheim International GmbH.[13] Spesolimab was approved for medical use in the European Union in December 2022.[5][14]

References

  1. ↑ 1.0 1.1 https://www.tga.gov.au/resources/auspmd/spevigo
  2. ↑ "Summary Basis of Decision for Spevigo". 21 June 2023. https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD1687438952638. 
  3. ↑ "Details for: Spevigo". 11 May 2023. https://dhpp.hpfb-dgpsa.ca/dhpp/resource/102523. 
  4. ↑ 4.0 4.1 4.2 4.3 4.4 4.5 "Spevigo- spesolimab-sbzo injection". 1 September 2022. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=41a481ee-3062-45d1-aed5-17e8b105634d. 
  5. ↑ 5.0 5.1 5.2 "Spevigo EPAR". 12 October 2022. https://www.ema.europa.eu/en/medicines/human/EPAR/spevigo.  Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
  6. ↑ 6.00 6.01 6.02 6.03 6.04 6.05 6.06 6.07 6.08 6.09 6.10 6.11 "Drug Trials Snapshots: Spevigo". 1 September 2022. https://www.fda.gov/drugs/drug-approvals-and-databases/drug-trials-snapshots-spevigo.  This article incorporates text from this source, which is in the public domain.
  7. ↑ "Drug Approval Package: Spevigo". https://www.accessdata.fda.gov/drugsatfda_docs/nda/2022/761244Orig1s000TOC.cfm. 
  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. ↑ "Spesolimab: First Approval". Drugs 82 (17): 1681–1686. November 2022. doi:10.1007/s40265-022-01801-4. PMID 36418672. 
  11. ↑ "Advancing Health Through Innovation: New Drug Therapy Approvals 2022". 10 January 2023. https://www.fda.gov/drugs/new-drugs-fda-cders-new-molecular-entities-and-new-therapeutic-biological-products/new-drug-therapy-approvals-2022.  This article incorporates text from this source, which is in the public domain.
  12. ↑ (PDF) New Drug Therapy Approvals 2022 (Report). January 2024. https://www.fda.gov/media/164429/download. Retrieved 14 January 2024.  This article incorporates text from this source, which is in the public domain.
  13. ↑ 13.0 13.1 "Spevigo: Pending EC decision". 14 October 2022. https://www.ema.europa.eu/en/medicines/human/summaries-opinion/spevigo.  Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
  14. ↑ "Spevigo Product information". 12 December 2022. https://ec.europa.eu/health/documents/community-register/html/h1688.htm. 

External links

  • Clinical trial number NCT03782792 for "Effisayil 1: A Study to Test Spesolimab (BI 655130) in Patients With a Flare-up of a Skin Disease Called Generalized Pustular Psoriasis" at ClinicalTrials.gov




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