Section 3 of 6

Product information and disease description

76 evidence topics · 64 sources

Product description

Phase of product development

Product name, regulatory status, and anticipated FDA action

“Quimilza™ (imsidolimab) BLA for GPP under review by the FDA; PDUFA target action date of December 12, 2026” (opens the source at this quote in a new tab)

Regulatory submission: BLA submitted December 2025

“In December 2025, we submitted the Biologics License Application (BLA) for imsidolimab for the treatment of GPP” (opens the source at this quote in a new tab)

“submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for imsidolimab” (opens the source at this quote in a new tab)

Launch: Anticipated in the first half of 2027

“We do not expect that we will be commercially launching right after the PDUFA date. There will be some lag time, but hopefully we can do that within the first half of 2027.” (opens the source at this quote in a new tab)

FDA filing acceptance

“has accepted the filing of its Biologics License Application (BLA) for imsidolimab for the treatment of Generalized Pustular Psoriasis (GPP)” (opens the source at this quote in a new tab)

Orphan drug designation: United States

“In July 2020, the FDA granted orphan drug designation to imsidolimab for the treatment of GPP based upon GALLOP clinical data.” (opens the source at this quote in a new tab)

Orphan drug designation: Japan

“Japan's Ministry of Health, Labour and Welfare (MHLW) has granted orphan drug designation to imsidolimab” (opens the source at this quote in a new tab)

Orphan designation: European Union

“its investigational drug imsidolimab has received Orphan Designation from the European Commission” (opens the source at this quote in a new tab)

Product information

Generic, brand name and therapeutic class of product

Manufacturer: Vanda Pharmaceuticals

“Vanda will receive an exclusive global license to develop, manufacture and commercialize imsidolimab.” (opens the source at this quote in a new tab)

Product names in the development update

“Quimilza™ (imsidolimab)” (opens the source at this quote in a new tab)

Drug class and molecular description

“Imsidolimab is a fully humanized IgG4 monoclonal antibody that inhibits IL-36 receptor signaling” (opens the source at this quote in a new tab)

Dosage forms and strengths

Investigational formulation concentration in the GALLOP protocol

“100 mg/mL” (opens the source at this quote in a new tab)

Material safety data sheet

No evidence found.

Average sales price and wholesale acquisition cost

Not applicable.

American hospital formulary service (AHFS), or other drug classification

Other classification in the Dutch horizon scan

“Interleukin inhibitor” (opens the source at this quote in a new tab)

AHFS classification code

No evidence found.

Indication

Investigational indication in the Dutch horizon scan

“Imsidolimab monotherapy for treatment of generalised pustular psoriasis in adults and elderly.” (opens the source at this quote in a new tab)

Pharmacology

Mechanism of action

Proposed mechanism of action

“Imsidolimab inhibits IL-36 receptor signaling, addressing the deficiency in the endogenous IL-36 receptor antagonist commonly observed in patients with GPP.” (opens the source at this quote in a new tab)

Pharmacodynamics

Phase 1 pharmacodynamics: duration of suppression and ex vivo assay

“completely suppress IL-36 cytokine function for 85 days” (opens the source at this quote in a new tab)
“IL-36 cytokine-mediated release of IL-8 using an ex vivo pharmacodynamic assay.” (opens the source at this quote in a new tab)

Pharmacokinetics

Pharmacokinetics: phase 1 healthy-volunteer study

“half-life of ANB019 was approximately 28 days for both subcutaneous and intravenous routes of administration, with bioavailability of approximately 90%.” (opens the source at this quote in a new tab)

“Median terminal half life ranged between 597 and 689 hours (25 to 29 days).” (opens the source at this quote in a new tab)
“Bioavailability was approximately 90%” (opens the source at this quote in a new tab)

Contraindications/Warnings/Precautions/Adverse effects

Warnings and precautions

Not applicable.

Special populations

Pregnancy and lactation: GALLOP exclusion criterion

“Pregnant or lactating females, or females who intend to become pregnant during the study period.” (opens the source at this quote in a new tab)

Pediatric, renal impairment, and hepatic impairment data

No evidence found.

Drug/Drug, drug/disease interactions

Effects of other drugs on Imsidolimab

No evidence found.

Effects of Imsidolimab on other drugs

No evidence found.

Dosing and administration

Dosage

Investigational acute-flare doses in GEMINI-1

“750mg IV imsidolimab, 300mg IV imsidolimab or placebo” (opens the source at this quote in a new tab)

Investigational regimen in GALLOP

“750mg IV dose of imsidolimab” (opens the source at this quote in a new tab)
“monthly 100mg subcutaneous dose of imsidolimab beginning at Week 4 and continued through Week 12.” (opens the source at this quote in a new tab)

Administration

Administration setting in the clinical protocol

“ANB019 should be administered in an environment under close supervision of a physician and where full resuscitation facilities are immediately available.” (opens the source at this quote in a new tab)

Access and distribution

No evidence found.

Co-prescribed/Concomitant therapies

GALLOP: prior and concomitant treatment restrictions

“Patients were washed out of prior therapy and no concomitant therapy was permitted during the trial.” (opens the source at this quote in a new tab)

Effect of Imsidolimab on quality measures

No evidence found.

Product comparison

Comparator indication: spesolimab

“treatment of generalized pustular psoriasis (GPP) in adults and pediatric patients 12 years of age and older and weighing at least 40 kg.” (opens the source at this quote in a new tab)

Subcutaneous spesolimab 1-ml formulation: terminated NICE technology appraisal TA1144

“Boehringer Ingelheim has confirmed that it does not intend to make an evidence submission for the appraisal.” (opens the source at this quote in a new tab)

Place of product in therapy

Disease description

Definition and etiology

Definition

“Generalized Pustular Psoriasis is a systemic inflammatory disease characterized by cutaneous erythema and macroscopically visible sterile pustules.” (opens the source at this quote in a new tab)

Identified flare triggers

“stress (19.4–21.4%), infections (19.4–21.4%), and treatment withdrawal (7.1–20.0%; none due to the withdrawal of steroids)” (opens the source at this quote in a new tab)

Epidemiology

Incidence of Generalized pustular psoriasis

France incidence

“Annually, there were 0.5–0.8 new GPP cases per 100,000 people.” (opens the source at this quote in a new tab)

Prevalence of Generalized pustular psoriasis

United States prevalence

“60 had a diagnosis of GPP (0.015%; 95% CI, 0.01-0.02)” (opens the source at this quote in a new tab)
“There are 150 GPP cases per million persons amongst US adults.” (opens the source at this quote in a new tab)
“Our reported prevalence may be an underestimation due to limited awareness about this disease, resulting in under- or misdiagnoses.” (opens the source at this quote in a new tab)

England population-based cohort

“the prevalence rate for GPP in our study in 2019 was 3.00 cases per 100 000 people” (opens the source at this quote in a new tab)

France epidemiology

“In 2017, the cumulative incidence and cumulative GPP age–sex standardized prevalence were 7.1 and 45.2 per million, respectively.” (opens the source at this quote in a new tab)

Natural history, survival, and mortality

National Psoriasis Foundation consensus: acuity of flares and causes of death

“GPP is a life-threatening disease that needs to be treated as quickly as possible.” (opens the source at this quote in a new tab)
“Acute flares of GPP can be life-threatening, with one-half of patients requiring hospitalization and a mortality rate of approximately 3 deaths per 100 patient years.” (opens the source at this quote in a new tab)
“most common causes of mortality include sepsis and multiorgan failure. Patients receiving biologics have lower in-hospital mortality than those receiving oral agents or corticosteroids alone.” (opens the source at this quote in a new tab)

France survival

“Twelve-month survival was 86.9% (GPP), 97.5% (plaque psoriasis), and 90.0% (the general population).” (opens the source at this quote in a new tab)

Flare recurrence

“150 patients with a baseline flare were included in this analysis” (opens the source at this quote in a new tab)
“27.3% (n=41) experienced flare recurrence during the follow-up period (mean duration: 4.16 years).” (opens the source at this quote in a new tab)

Five-year mortality

“GPP patients had higher 5-year mortality than PV (HR, 1.83; 95% CI, 1.28–2.59)” (opens the source at this quote in a new tab)

United States mortality claims analysis

“Patients with GPP exhibited an elevated mortality risk in comparison to the matched plaque-PsO and general population cohorts.” (opens the source at this quote in a new tab)

Mortality systematic review and meta-analysis

“All-cause mortality was 1.78 times higher (95% confidence interval [CI]: 1.52–2.09; P < 0.0001) for GPP than for plaque psoriasis” (opens the source at this quote in a new tab)

Pathophysiology

“Aberrant interleukin-36Ra structure and function lead to unregulated secretion of inflammatory cytokines and generalized pustular psoriasis.” (opens the source at this quote in a new tab)

Diagnosis

ERASPEN consensus definitions

“primary, sterile, macroscopically visible pustules on non-acral skin (excluding cases where pustulation is restricted to psoriatic plaques).” (opens the source at this quote in a new tab)

International consensus: essential diagnostic criterion

“Macroscopically visible sterile pustules on erythematous base and not restricted to the acral region or within psoriatic plaques.” (opens the source at this quote in a new tab)

Japanese guidelines

“Its contents include the diagnostic and severity classification criteria for GPP, its pathogenesis, and recommendations for the treatment of GPP.” (opens the source at this quote in a new tab)

Global Delphi consensus: genetic testing

“Genetic testing is helpful for GPP diagnosis, when available; screening for IL36RN mutations is recommended” (opens the source at this quote in a new tab)

Clinical presentation - signs and symptoms

Cutaneous symptoms: pain and rash during flare episodes

“pain (61% of flare episodes [312 of 513])” (opens the source at this quote in a new tab)
“rash (46% [236 of 513])” (opens the source at this quote in a new tab)

Constitutional symptoms: fever during flare episodes

“fever (45% [229 of 513])” (opens the source at this quote in a new tab)

Long-term morbidity

France: comorbidities in GPP versus plaque psoriasis and general population cohorts

“hypertension (37% vs 21% and 20%), obesity (21% vs 9% and 6%), depression (13% vs 4% and 4%)” (opens the source at this quote in a new tab)

Burden of Generalized pustular psoriasis

Humanistic burden and health-related quality of life

Health-related quality-of-life systematic review

“In total 44 records that reported on 20 studies met the eligibility criteria and were retained for data extraction.” (opens the source at this quote in a new tab)

France: patient-reported burden

“High scores for fatigue, stress, skin and joint pain were reported, with 65% of patients at risk of mild to severe depression.” (opens the source at this quote in a new tab)

Patient-reported burden

“Dermatology Life Quality Index scores indicated a moderate to extremely large impact on QoL in nine patients (50%).” (opens the source at this quote in a new tab)

Sweden health-related quality of life

“The HRQoL was significantly worse in individuals with GPP compared to individuals with plaque psoriasis.” (opens the source at this quote in a new tab)

Malaysia health-related quality of life

“DLQI and EQ-5D for the patients with GPP were 8.44 (SD: 7.12) and 0.74 (SD: 0.27), respectively.” (opens the source at this quote in a new tab)

Real-world evidence review

“The impact of GPP on patients’ daily activities was significant, even in the absence of a flare.” (opens the source at this quote in a new tab)

Economic burden and healthcare resource utilization

United States case series

“In the initial encounter, 35 patients (36.8%) were hospitalized and 64 (67.4%) were treated with systemic therapies.” (opens the source at this quote in a new tab)

Economic burden systematic review

“ten eligible studies” (opens the source at this quote in a new tab)
“across five countries” (opens the source at this quote in a new tab)
“the leading cost drivers for GPP were the costs of inpatient admissions and medications.” (opens the source at this quote in a new tab)

United States economic burden

“GPP patients experienced significantly higher total healthcare costs compared to matched cohorts (GPP vs plaque psoriasis: cost ratio 1.36, 95% confidence interval (1.22, 1.50); GPP vs control: 5.58 (3.73, 8.36)).” (opens the source at this quote in a new tab)
“Rates of inpatient visits were 4 times higher in GPP patients and 2 times higher in PPP patients compared to their matched cohorts.” (opens the source at this quote in a new tab)
“GPP and PPP patients have significant economic burden due to higher direct medical and pharmacy costs.” (opens the source at this quote in a new tab)

United States healthcare utilization, flares, and severity

“GPP patients who flared and had more severe disease had greater HCRU and charges.” (opens the source at this quote in a new tab)

Finland economic burden

“Flares were also associated with 2.5-fold higher indirect costs (cost ratio 2.5; 95% CI, 1.6–4.0; p < 0.001) compared with no flares.” (opens the source at this quote in a new tab)

Taiwan national claims study

“Median monthly healthcare costs were approximately twice as high among patients with GPP as among matched patients with PV.” (opens the source at this quote in a new tab)

Economic impact of Generalized pustular psoriasis on families

No evidence found.

Economic impact of diagnostic testing

Not applicable.

Approaches to treatment

Current treatment options and standard of care

IL-36 receptor inhibitors

Asia-Pacific consensus

“Spesolimab is the preferred biologic treatment for the management of acute flares” (opens the source at this quote in a new tab)

TNF inhibitors

Expert recommendations: position of cytokine-targeted biologics other than IL-36 inhibitors

“Systemic Biologics That Target the Predominant Cytokines in Plaque Psoriasis Should Be Considered Second-Line Therapy for the Treatment of GPP” (opens the source at this quote in a new tab)

TNF inhibitors described in the treatment recommendations

“adalimumab, infliximab, and certolizumab pegol” (opens the source at this quote in a new tab)

IL-17 inhibitors

Asia-Pacific consensus: maintenance treatment

“IL-17 inhibitors can be used for maintenance phase” (opens the source at this quote in a new tab)

IL-23 inhibitors

Asia-Pacific consensus: maintenance treatment

“IL-23 inhibitors can be used for maintenance phase” (opens the source at this quote in a new tab)

Conventional systemic therapies

Non-biologic systemic agents described in the treatment recommendations

“corticosteroids (prednisone/prednisolone), cyclosporine, methotrexate, or acitretin” (opens the source at this quote in a new tab)

Asia-Pacific consensus: systemic corticosteroids for maintenance

“systemic corticosteroids are not recommended as maintenance therapy” (opens the source at this quote in a new tab)

Topical therapies

Topical corticosteroids as maintenance or adjunctive therapy

“topical corticosteroids may be considered in some cases for maintenance or adjunctive therapy” (opens the source at this quote in a new tab)

United States treatment patterns

“Topical corticosteroids were the most frequently prescribed treatment postdiagnosis, followed by systemic corticosteroids” (opens the source at this quote in a new tab)

Phototherapy

Japanese guidelines: acute-phase restriction

“Phototherapy is not indicated for acute phase pustular psoriasis” (opens the source at this quote in a new tab)

Granulocyte and monocyte adsorption apheresis

Japanese guidelines: treatment option

“Granulocyte/monocyte adsorption apheresis (GMA) is included as a treatment choice” (opens the source at this quote in a new tab)

Supportive care

Supportive care and hospital admission

“An important aspect of current management strategies is supportive care, often including hospital admission.” (opens the source at this quote in a new tab)

Limitations of current therapies

Summary

A treatment review included 118 publications, of which 19% reported clinical trial results. A separate biologics meta-analysis identified moderate heterogeneity and publication bias as limitations affecting reliability. In a U.S. flare-episode analysis, 122 of 513 episodes (24%) had no dermatologic treatment in the interval encompassing the 30 days before, during, and 30 days after the flare. These findings describe limitations of the evidence base and observed treatment delivery; they do not establish comparative efficacy between imsidolimab and existing therapies.

Treatment gaps during flare episodes

“(24% [122 of 513]) had no dermatologic treatment 30 days before, during, or 30 days after a flare episode.” (opens the source at this quote in a new tab)

Biologics systematic review and single-arm meta-analysis

“Moderate heterogeneity and publication bias in the included studies may affect the reliability of the results.” (opens the source at this quote in a new tab)

Treatment systematic literature review

“In total, 118 publications were included, with only 19% of publications reporting on the results of clinical trials.” (opens the source at this quote in a new tab)

National Psoriasis Foundation consensus: access to approved therapy

“We strongly advocate for timely access to US Food and Drug Administration-approved therapies for GPP because delays can increase the risk of mortality in patients with this rapidly progressing disease.” (opens the source at this quote in a new tab)
“Spesolimab is the first US Food and Drug Administration-approved treatment that is highly effective in the treatment of GPP flares in adults.” (opens the source at this quote in a new tab)
“Timely access to approved therapies is critical to reducing morbidity and mortality in patients presenting with GPP.” (opens the source at this quote in a new tab)

National Psoriasis Foundation consensus: diagnostic criteria should not gate treatment

“Skin biopsy is not required for the diagnosis of GPP because histologic features may be nonspecific and it may delay treatment of this life-threatening condition.” (opens the source at this quote in a new tab)
“Although GPP phenotype classification criteria from the European Rare and Severe Psoriasis Expert Network and Japanese Dermatological Association are informative for clinical trials, these criteria should not be used to deny or delay treatment in clinical practice.” (opens the source at this quote in a new tab)
“in patients presenting with acute GPP, one should not wait to fulfill certain arbitrary definitions of GPP before initiating treatment.” (opens the source at this quote in a new tab)

Place in treatment, anticipated use, and care setting

Summary

The imsidolimab phase 3 program evaluated IV treatment of GPP flares and subcutaneous maintenance among initial responders. These studies used placebo comparisons rather than an active comparison with spesolimab. The Asia-Pacific consensus included in this report identifies spesolimab as the preferred biologic for acute flares. An imsidolimab treatment position therefore remains investigational while the BLA is under review. The GALLOP protocol specifies physician supervision and availability of full resuscitation facilities for administration.

Heterogeneity of treatment effect

No evidence found.

Care management intervention strategies

Multidisciplinary management and monitoring during flares

“A multidisciplinary approach is required for GPP disease management.” (opens the source at this quote in a new tab)
“Patients should be carefully monitored by a dermatologist throughout a flare” (opens the source at this quote in a new tab)

Ongoing post-approval monitoring

Not applicable.

Expected outcomes of therapy

Global Delphi consensus: treatment goals

“Short-term treatment goals should include pustule clearance within 7 days and prevention of pustule recurrence” (opens the source at this quote in a new tab)
“minimizing disease activity through flare prevention” (opens the source at this quote in a new tab)