Spesolimab

Spesolimab
Monoclonal antibody
Type	Whole antibody
Source	Humanized
Target	Interleukin 36 receptor (IL1RL2/IL1RAP)
Clinical data
Trade names	Spevigo
Other names	BI-655130, spesolimab-sbzo
AHFS/Drugs.com	Monograph
License data	US DailyMed: Spesolimab;
Pregnancy; category	AU: B1; ;
Routes of; administration	Intravenous
ATC code	L04AC22 (WHO) ;
Legal status
Legal status	AU: S4 (Prescription only); CA: ℞-only; US: ℞-only; EU: Rx-only;
Identifiers
CAS Number	2097104-58-8;
DrugBank	DB15626;
UNII	5IB2J79MCX;
KEGG	D12066;
Chemical and physical data
Formula	C6480H9988N1736O2012S46
Molar mass	145880.08 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]

The FDA granted the application breakthrough therapy designation.^[15]

References

^ ^a ^b "Spevigo APMDS". Therapeutic Goods Administration (TGA). 8 December 2023. Archived from the original on 2 January 2024. Retrieved 7 March 2024.
^ "Summary Basis of Decision for Spevigo". Health Canada. 21 June 2023. Archived from the original on 20 August 2023. Retrieved 20 August 2023.
^ "Details for: Spevigo". Health Canada. 11 May 2023. Archived from the original on 20 August 2023. Retrieved 20 August 2023.
^ ^a ^b ^c ^d ^e ^f "Spevigo- spesolimab-sbzo injection". DailyMed. 1 September 2022. Archived from the original on 16 October 2022. Retrieved 16 October 2022.
^ ^a ^b ^c "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.
^ ^a ^b ^c ^d ^e ^f ^g ^h ⁱ ^j ^k ^l "Drug Trials Snapshots: Spevigo". U.S. Food and Drug Administration (FDA). 1 September 2022. Archived from the original on 4 December 2023. Retrieved 4 December 2023. This article incorporates text from this source, which is in the public domain.
^ "Drug Approval Package: Spevigo". U.S. Food and Drug Administration (FDA). Archived from the original on 26 December 2022. Retrieved 2 September 2022.
^ "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.
^ "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.
^ Blair HA (November 2022). "Spesolimab: First Approval". Drugs. 82 (17): 1681–1686. doi:10.1007/s40265-022-01801-4. PMC 9744699. PMID 36418672.
^ "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. This article incorporates text from this source, which is in the public domain.
^ 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. This article incorporates text from this source, which is in the public domain.
^ ^a ^b "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.
^ "Spevigo Product information". Union Register of medicinal products. 12 December 2022. Archived from the original on 16 December 2022. Retrieved 3 March 2023.
^ "CY 2024 CDER Breakthrough Therapy Calendar Year Approvals" (PDF). U.S. Food and Drug Administration (FDA). 30 September 2024.

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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[Spevigo_APMDS-1] "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.

[Spevigo_FDA_label-4] ^ ^a ^b ^c ^d ^e ^f "Spevigo- spesolimab-sbzo injection". DailyMed. 1 September 2022. Archived from the original on 16 October 2022. Retrieved 16 October 2022.

[Spevigo_EPAR-5] "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.

[Spevigo_FDA_snapshot-6] ^ ^a ^b ^c ^d ^e ^f ^g ^h ⁱ ^j ^k ^l "Drug Trials Snapshots: Spevigo". U.S. Food and Drug Administration (FDA). 1 September 2022. Archived from the original on 4 December 2023. Retrieved 4 December 2023. This article incorporates text from this source, which is in the public domain.

[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.

[pmid36418672-10] Blair HA (November 2022). "Spesolimab: First Approval". Drugs. 82 (17): 1681–1686. doi:10.1007/s40265-022-01801-4. PMC 9744699. PMID 36418672.

[New_Drug_Therapy_Approvals_2022-11] "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. 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. This article incorporates text from this source, which is in the public domain.

[Spevigo:_Pending_EC_decision-13] "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.

[14] "Spevigo Product information". Union Register of medicinal products. 12 December 2022. Archived from the original on 16 December 2022. Retrieved 3 March 2023.

[CY_2024_CDER_Breakthrough_Therapy_Calendar_Year_Approvals-15] "CY 2024 CDER Breakthrough Therapy Calendar Year Approvals" (PDF). U.S. Food and Drug Administration (FDA). 30 September 2024.

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