Spesolimab Explained

Type:mab
Mab Type:mab
Source:zu
Target:Interleukin 36 receptor (IL1RL2/IL1RAP)
Tradename:Spevigo
Dailymedid:Spesolimab
Pregnancy Au:B1
Routes Of Administration:Intravenous
Atc Prefix:L04
Atc Suffix:AC22
Legal Au:S4
Legal Au Comment:[1]
Legal Ca:Rx-only
Legal Ca Comment:[2] [3]
Legal Us:Rx-only
Legal Us Comment:[4]
Legal Eu:Rx-only
Cas Number:2097104-58-8
Drugbank:DB15626
Unii:5IB2J79MCX
Kegg:D12066
Synonyms:BI-655130, spesolimab-sbzo
C:6480
H:9988
N:1736
O:2012
S:46

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

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

It was approved for medical use in the United States in September 2022,[5] [6] [7] [8] and in European Union in December 2022. The US Food and Drug Administration (FDA) considers it to be a first-in-class medication.[9] [10]

Medical uses

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

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. The trial was conducted at three sites in the United States and 23 sites globally (Africa, Asia, and Europe). Spesolimab was evaluated in one clinical trial (Study Effisayil-1/NCT03782792) of 53 adults with generalized pustular psoriasis flare. In the trial, participants received a single treatment with either spesolimab or placebo. 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. Neither the participant nor the healthcare providers knew which treatment was being given until after week 1. 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). 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.[11]

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. The applicant for this medicinal product is Boehringer Ingelheim International GmbH.[12] Spesolimab was approved for medical use in the European Union in December 2022.[13] [14]

Notes and References

  1. Web site: Spevigo APMDS . Therapeutic Goods Administration (TGA) . 8 December 2023 . 7 March 2024 . 2 January 2024 . https://web.archive.org/web/20240102020320/https://www.tga.gov.au/resources/auspmd/spevigo . live .
  2. Web site: Summary Basis of Decision for Spevigo . . 21 June 2023 . 20 August 2023 . 20 August 2023 . https://web.archive.org/web/20230820200050/https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD1687438952638 . live .
  3. Web site: Details for: Spevigo . . 11 May 2023 . 20 August 2023 . 20 August 2023 . https://web.archive.org/web/20230820200120/https://dhpp.hpfb-dgpsa.ca/dhpp/resource/102523 . live .
  4. Web site: Spevigo- spesolimab-sbzo injection . DailyMed . 1 September 2022 . 16 October 2022 . 16 October 2022 . https://web.archive.org/web/20221016044635/https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=41a481ee-3062-45d1-aed5-17e8b105634d . live .
  5. Web site: Drug Approval Package: Spevigo . U.S. Food and Drug Administration (FDA) . 2 September 2022 . 26 December 2022 . https://web.archive.org/web/20221226070344/http://www.accessdata.fda.gov/drugsatfda_docs/nda/2022/761244Orig1s000TOC.cfm . live .
  6. U.S. FDA approves first treatment option for generalized pustular psoriasis flares in adults . Boehringer Ingelheim . 2 September 2022 . 2 September 2022 . https://web.archive.org/web/20220902072527/https://www.boehringer-ingelheim.com/human-health/skin-diseases/fda-approves-first-gpp-flare-treatment . live .
  7. U.S. FDA approves first treatment option for generalized pustular psoriasis flares in adults . Boehringer Ingelheim . Business Wire . 2 September 2022 . 2 September 2022 . 2 September 2022 . https://web.archive.org/web/20220902064033/http://www.businesswire.com/news/home/20220901005863/en/U.S.-FDA-approves-first-treatment-option-for-generalized-pustular-psoriasis-flares-in-adults/ . live .
  8. Blair HA . Spesolimab: First Approval . Drugs . 82 . 17 . 1681–1686 . November 2022 . 36418672 . 9744699 . 10.1007/s40265-022-01801-4 .
  9. Web site: Advancing Health Through Innovation: New Drug Therapy Approvals 2022 . U.S. Food and Drug Administration (FDA) . 10 January 2023 . 22 January 2023 . 21 January 2023 . https://web.archive.org/web/20230121035714/https://www.fda.gov/drugs/new-drugs-fda-cders-new-molecular-entities-and-new-therapeutic-biological-products/new-drug-therapy-approvals-2022 . live .
  10. New Drug Therapy Approvals 2022 . U.S. Food and Drug Administration (FDA) . January 2024 . PDF . 14 January 2024 . https://web.archive.org/web/20240114065648/https://www.fda.gov/media/164429/download . 14 January 2024 . live .
  11. Web site: Drug Trials Snapshots: Spevigo . U.S. Food and Drug Administration (FDA) . 1 September 2022 . 4 December 2023 . 4 December 2023 . https://web.archive.org/web/20231204033555/https://www.fda.gov/drugs/drug-approvals-and-databases/drug-trials-snapshots-spevigo . live .
  12. Web site: Spevigo: Pending EC decision . European Medicines Agency . 14 October 2022 . 15 October 2022 . 15 October 2022 . https://web.archive.org/web/20221015011839/https://www.ema.europa.eu/en/medicines/human/summaries-opinion/spevigo . live . Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
  13. Web site: Spevigo EPAR . European Medicines Agency (EMA) . 12 October 2022 . 8 February 2023 . 8 February 2023 . https://web.archive.org/web/20230208191157/https://www.ema.europa.eu/en/medicines/human/EPAR/spevigo . live . Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
  14. Web site: Spevigo Product information . Union Register of medicinal products . 12 December 2022 . 3 March 2023 . 16 December 2022 . https://web.archive.org/web/20221216114513/https://ec.europa.eu/health/documents/community-register/html/h1688.htm . live .

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