Section 3 of 6

Product information and disease description

77 evidence topics · 59 sources

Product description

Phase of product development

FDA submission and designations

“the submission of a Biologics License Application (BLA)” (opens the source at this quote in a new tab)
“FDA has granted Hansa Biopharma Fast Track and Orphan Drug Designation and Hansa has requested Priority Review” (opens the source at this quote in a new tab)

Regulatory submission: BLA submitted December 2025

“Lund, Sweden, 19 December 2025.” (opens the source at this quote in a new tab)
“today announced the submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for imlifidase.” (opens the source at this quote in a new tab)

FDA acceptance

“Hansa Biopharma’s Biologics License Application (BLA) for imlifidase accepted by the FDA” (opens the source at this quote in a new tab)

PDUFA action date

“December 19, 2026” (opens the source at this quote in a new tab)

Launch: Anticipated in the first quarter of 2027

“Imlifidase Potentially Available in Q1 2027*” (opens the source at this quote in a new tab)
“*Subject to FDA Approval” (opens the source at this quote in a new tab)

European authorization

“Idefirix received a conditional marketing authorisation valid throughout the EU on 25 August 2020.” (opens the source at this quote in a new tab)

Product information

Generic, brand name and therapeutic class of product

Manufacturer: Hansa Biopharma

“Hansa Biopharma AB, (“Hansa” or “the Company”), (Nasdaq Stockholm: HNSA), today announced that its Biologics License Application (BLA) for imlifidase has been accepted” (opens the source at this quote in a new tab)

Product identity

“Idefirix contains the active substance imlifidase.” (opens the source at this quote in a new tab)

Dosage forms and strengths

Vial content

“Each vial contains 11 mg imlifidase produced in Escherichia coli cells by recombinant DNA technology.” (opens the source at this quote in a new tab)

Pharmaceutical form

“Powder for concentrate for solution for infusion” (opens the source at this quote in a new tab)

Material safety data sheet for the medicinal product

No evidence found.

Average sales price and wholesale acquisition cost

United States average sales price and wholesale acquisition cost

No evidence found.

Irish economic assessment: wholesaler price and two-vial cost excluding VAT

Cost input	Quoted amount
Wholesaler price per vial	“€148,080.77”
Two-vial cost	“€296,161.54”

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

Pharmacotherapeutic classification

“Pharmacotherapeutic group: Immunosuppressants, selective immunosuppressants, ATC code: L04AA41.” (opens the source at this quote in a new tab)

Indication

European indication

“desensitization treatment of highly sensitized adult kidney transplant patients with a positive crossmatch against an available deceased donor.” (opens the source at this quote in a new tab)

Pharmacology

Mechanism of action

“Imlifidase is an IgG-inactivating therapy based on a cysteine protease originating from Streptococcus pyogenes.” (opens the source at this quote in a new tab)
“cleaves IgG-antibodies and inhibits their activity within hours after administration.” (opens the source at this quote in a new tab)

Pharmacodynamics

Pharmacodynamics and immunogenicity: NCT02224820

“<1% plasma IgG remaining within 48 hours” (opens the source at this quote in a new tab)
“Anti-IdeS antibodies developed 1 week after treatment, peaking at 2 weeks.” (opens the source at this quote in a new tab)

Phase 1 study in healthy subjects: NCT01802697

“Twenty healthy subjects were given intravenous single ascending doses of IdeS.” (opens the source at this quote in a new tab)
“IgG reached nadir 6-24 hours after dosing and then slowly recovered.” (opens the source at this quote in a new tab)

Imlifidase-generated single-cleaved IgG

“ScIgG has a significantly reduced capacity to mediate Fc-dependent effector functions.” (opens the source at this quote in a new tab)

F(ab′)2 fragments and complement activation: in vitro study

“F(ab′)2 fragments generated from anti-HLA antibodies after imlifidase cleavage had a biological impact on intact IgG binding, leading to reduced complement activation.” (opens the source at this quote in a new tab)

Anti-IdeS antibodies in healthy humans

“clinically significant levels of IdeS-neutralizing activity were found in only ~1% of the individuals tested.” (opens the source at this quote in a new tab)

Pharmacokinetics

“Quoted elimination half life of imlifidase is 89 (60-238) hours.” (opens the source at this quote in a new tab)

Product information: pharmacokinetic parameters

Parameter	Quoted value
Mean maximum concentration after 0.25 mg/kg	“5.8 (4.2‑8.9) µg/mL”
Mean distribution half-life	“1.8 (0.6‑3.6) hours”
Mean elimination half-life	“89 (60‑238) hours”
Mean clearance	“1.8 (0.6‑7.9) mL/h/kg”
Mean distribution volume during elimination	“0.20 (0.06‑0.55) L/kg”

Contraindications/Warnings/Precautions/Adverse effects

Warnings and precautions

Serious adverse reactions

“The most common serious adverse reactions in clinical studies were pneumonia (5.6%) and sepsis (3.7%).” (opens the source at this quote in a new tab)

Selected contraindications

“Ongoing serious infection.” (opens the source at this quote in a new tab)
“Thrombotic thrombocytopenic purpura (TTP).” (opens the source at this quote in a new tab)

Identified risks and infection prevention

“Severe or serious infection” (opens the source at this quote in a new tab)
“Infusion-related reactions” (opens the source at this quote in a new tab)
“To minimise the risk of infections, all patients should receive treatment with antibiotics.” (opens the source at this quote in a new tab)

Interference with alloantibody screening: case report

“Following imlifidase treatment, alloantibody screening prior to blood transfusion returned a false-negative result” (opens the source at this quote in a new tab)

Interference with protein electrophoresis and immunofixation

“In conclusion, imlifidase is a new exogenous substance that interferes with SPE, ISE and IFE in a new way.” (opens the source at this quote in a new tab)

Special populations

Hepatic impairment and pediatric populations

Population	Quoted safety and efficacy information
Moderate or severe hepatic impairment	“have not been established. No data are available.”
Children and adolescents younger than 18 years	“No data are available.”

Drug/Drug, drug/disease interactions

Effects of other drugs on Imlifidase

Drug interactions

“Avoid intravenous immunoglobulins within four weeks and other IgG-based biologics within two weeks before imlifidase because of potential enzyme neutralisation or loss of biologic effect.” (opens the source at this quote in a new tab)

Neutralizing antibodies in intravenous immunoglobulin preparations

“anti-IdeS IgG capable of neutralizing IdeS enzymatic activity in therapeutic preparations of pooled normal human IgG (IVIg).” (opens the source at this quote in a new tab)

Effects of Imlifidase on other drugs

Potential impairment of alemtuzumab activity after imlifidase

“Alemtuzumab may not be effective on Day 4 in some patients (as imlifidase may still be active).” (opens the source at this quote in a new tab)

Dosing and administration

Dosage

Dose

“The recommended dose is 0.25 mg/kg administered as a single dose preferably within 24 hours before transplantation.” (opens the source at this quote in a new tab)

Administration

Route and infusion duration

“intravenous use only” (opens the source at this quote in a new tab)
“15 minutes” (opens the source at this quote in a new tab)

Premedication

“Pre-medication: IV chlorpheniramine 10mg and IV hydrocortisone 200mg to prevent infusion reactions.” (opens the source at this quote in a new tab)

Access and distribution

Hospital restriction

“Imlifidase is restricted to hospital use only.” (opens the source at this quote in a new tab)

European and MENA rights acquired by SERB

“completed the acquisition of exclusive development and commercialization rights to Idefirix® (imlifidase)” (opens the source at this quote in a new tab)

Co-prescribed/Concomitant therapies

French consensus protocol: accompanying immunosuppression

“steroids, rATG, high dose IVIg, rituximab, tacrolimus and mycophenolic acid.” (opens the source at this quote in a new tab)

Effect of Imlifidase on quality measures

Welsh commissioning requirements for quality monitoring

“The Provider must work to written quality standards and provide monitoring information to the lead commissioner.” (opens the source at this quote in a new tab)

Demonstrated effect on quality-measure performance

No evidence found.

Product comparison

ConfIdeS: randomized comparison of kidney function at 12 months

Outcome	Imlifidase arm	Control arm
Mean eGFR, mL/min/1.73 m²	“51.5”	“19.3”

Place of product in therapy

Disease description

Definition and etiology

Kidney failure

“If your kidney function drops below 15 percent of normal, you are said to have kidney failure.” (opens the source at this quote in a new tab)

Sensitization risk factors

“Sensitization usually occurs as a consequence of pregnancy, blood transfusions, tissue graft or previous transplantation.” (opens the source at this quote in a new tab)

HLA sensitization

“their immune system makes antibodies against one or more HLA antigens or alleles in the donor pool.” (opens the source at this quote in a new tab)

Epidemiology

Incidence of Kidney transplantation in highly sensitized patients

No evidence found.

Prevalence of Kidney transplantation in highly sensitized patients

Transplant-waiting-list population

“Across the U.S. and Europe, highly sensitized patients comprise around 10-15% of the total of patients on transplant waiting lists.” (opens the source at this quote in a new tab)

Natural history, survival, and mortality

Transplant access and unmet need: background studies

“we found 1597 additional sensitized (CPRA 50–<99.9%) candidates with meaningfully lower than average access to transplant” (opens the source at this quote in a new tab)

“Although the TR increased sharply for the CPRA 99.9%+ group with KAS, it remained markedly lower than the average despite national priority.” (opens the source at this quote in a new tab)

Waiting time and mortality risk

“longer time waiting for a suitable donor relates to an increased mortality risk.” (opens the source at this quote in a new tab)

Pathophysiology

Antibody-mediated effector activity

“Antibody-dependent cell-mediated cytotoxicity (ADCC) is an important pathway responsible for antibody-mediated rejection (AMR).” (opens the source at this quote in a new tab)

Diagnosis

International Delphi consensus on imlifidase desensitization

“crossmatch conversion from positive to negative in patients treated with imlifidase should be confirmed before transplantation” (opens the source at this quote in a new tab)

Clinical presentation - signs and symptoms

Fluid retention: manifestations of kidney failure

“have swelling, usually in your legs, feet, or ankles” (opens the source at this quote in a new tab)

Fatigue and sleep disturbance: manifestations of kidney failure

“feel tired during the day and have sleep problems at night” (opens the source at this quote in a new tab)

Long-term morbidity

Cardiovascular burden in kidney disease

“Heart disease is the most common cause of death among people who have kidney disease.” (opens the source at this quote in a new tab)

Mineral and bone disorder in chronic kidney disease

“bones gradually become thin and weak.” (opens the source at this quote in a new tab)
“bones and joints may begin to feel painful.” (opens the source at this quote in a new tab)

Burden of Kidney transplantation in highly sensitized patients

Humanistic burden and health-related quality of life

Humanistic burden

“Kidney failure will change your day-to-day activities” (opens the source at this quote in a new tab)

Irish economic model: utility-data limitation

“Another limitation is that utility data specific to highly sensitised ESRD patients were not available.” (opens the source at this quote in a new tab)

Economic burden and healthcare resource utilization

In-center hemodialysis: treatment frequency and duration

“usually three times per week” (opens the source at this quote in a new tab)
“Each dialysis session lasts about 4 hours.” (opens the source at this quote in a new tab)

Irish economic model: probabilistic sensitivity analysis

“dominant versus SoC in 94.5% of model simulations” (opens the source at this quote in a new tab)

Economic impact of Kidney transplantation in highly sensitized patients on families

Background evidence: caregivers of children with chronic kidney disease in Egypt

“250 caregivers of children with CKD” (opens the source at this quote in a new tab)
“Although the majority (87.2%) of caregivers suffered different degrees of financial hardship” (opens the source at this quote in a new tab)

Costs borne by families of highly sensitized adult transplant candidates

No evidence found.

Economic impact of diagnostic testing

French selection pathway: cost implications of diluted-serum HLA testing

“This recommendation increases significantly the cost of HLA testing” (opens the source at this quote in a new tab)

Approaches to treatment

Current treatment options and standard of care

Compatible donor allocation and acceptable mismatch programs

European guidance on acceptable mismatch programs

“The Eurotransplant Acceptable Mismatch program should be extended.” (opens the source at this quote in a new tab)

Belgian consensus: Acceptable Mismatch program

“For patients who remain in the AM program for ≥3 y without undergoing transplantation, an additional prioritization strategy has been implemented.” (opens the source at this quote in a new tab)

Kidney paired exchange

European Society for Organ Transplantation guideline

“highly sensitized patients should not be left on a KEP list indefinitely if the option of a direct incompatible transplant exists.” (opens the source at this quote in a new tab)

Plasma exchange and immunoadsorption

Existing desensitization approaches

“Desensitisation is currently based on protocols using apheresis and/or medicinal products used off-label.” (opens the source at this quote in a new tab)

Guideline-supported antibody removal with adjunctive therapy

“plasma exchange or immunoadsorption, supplemented with IViG and/or anti-CD20 antibody.” (opens the source at this quote in a new tab)

Intravenous immunoglobulin

European consensus: first-line desensitization

“PEX and IVIg should be part of the first line desensitization strategy” (opens the source at this quote in a new tab)

B-cell-depleting antibodies

European consensus: adjunctive prevention of antibody rebound

“rituximab might be considered as an adjunct to prevent antibody rebound” (opens the source at this quote in a new tab)

IgG-cleaving enzyme therapy

French consensus guidelines: patient selection

“cPRA ≥ 98%, ≤ 65-year of age, ≥ 3 years on the waiting list, and a low risk of biopsy-related complications.” (opens the source at this quote in a new tab)

European Delphi consensus on sensitized kidney-transplant recipients

“imlifidase might be considered for deceased kidney transplantation in selected patients for whom there are no other treatment options” (opens the source at this quote in a new tab)

Induction and maintenance immunosuppression

Selected agents in the French imlifidase-enabled transplantation protocol

Treatment role	Quoted agent
T-cell-depleting induction	“rATG”
Calcineurin inhibition	“tacrolimus”
Antimetabolite maintenance	“mycophenolic acid”

Maintenance dialysis

Dialysis modalities for kidney failure

“hemodialysis” (opens the source at this quote in a new tab)
“peritoneal dialysis” (opens the source at this quote in a new tab)

Limitations of current therapies

Summary

Existing desensitization approaches include apheresis and off-label medicines. These regimens may require repeated treatment over weeks or months and may not reduce antibodies sufficiently to permit transplantation. Compatible allocation and kidney exchange do not resolve access for every highly sensitized candidate; United States analyses identified persistent access limitations even after allocation priority. European guidance advises against leaving highly sensitized candidates on a kidney exchange list indefinitely when an incompatible transplant is a feasible option. Some practical recommendations for imlifidase-enabled transplantation remain based on evidence that expert authors describe as lacking high-level scientific support.

Conventional desensitization: treatment duration and incomplete response

“repeated doses for several weeks or months prior to transplantation” (opens the source at this quote in a new tab)
“It does not always enable a sufficient reduction in antibodies to allow transplantation” (opens the source at this quote in a new tab)

German expert consensus: evidence limitations

“lack high-level scientific evidence” (opens the source at this quote in a new tab)

Place in treatment, anticipated use, and care setting

Summary

The cited European indication concerns highly sensitized adults with a positive crossmatch against an available deceased donor, and European consensus considers imlifidase for selected candidates without other treatment options. The French consensus specifies cPRA of at least 98%, age no greater than 65 years, at least three years on the waiting list, and low biopsy-complication risk; these are consensus selection criteria rather than a universal label restriction. Administration is restricted to hospital use. Crossmatch conversion must be confirmed before transplantation. The French protocol combines imlifidase with additional immunosuppression, and German consensus recommends considering an early protocol biopsy between days 7 and 10 when clinically feasible.

Heterogeneity of treatment effect

Baseline donor-specific antibodies and early rejection risk

“Patients with very high levels of DSA before transplantation are more likely to experience early AMR that requires intervention.” (opens the source at this quote in a new tab)

Care management intervention strategies

German expert consensus: biopsy surveillance

“an early protocol biopsy should be considered between days 7 and 10 after transplantation, where clinically feasible” (opens the source at this quote in a new tab)

Ongoing post-approval monitoring

European conditional authorization: long-term effectiveness follow-up

“The company that markets Idefirix will provide results of a long-term study of Idefirix to confirm its effectiveness.” (opens the source at this quote in a new tab)

Company-reported completion of the post-authorization efficacy study obligation

“the post-authorization obligation has now been fulfilled” (opens the source at this quote in a new tab)

Expected outcomes of therapy

European post-authorization efficacy study: one-year outcomes

“The 1-year graft failure-free survival was 90%” (opens the source at this quote in a new tab)
“graft survival was 92%, and patient survival was 98%.” (opens the source at this quote in a new tab)

FDA submission and designations

Regulatory submission: BLA submitted December 2025

FDA acceptance

PDUFA action date

Launch: Anticipated in the first quarter of 2027

European authorization

Manufacturer: Hansa Biopharma

Product identity

Vial content

Pharmaceutical form

Material safety data sheet for the medicinal product

United States average sales price and wholesale acquisition cost

Irish economic assessment: wholesaler price and two-vial cost excluding VAT

Pharmacotherapeutic classification

European indication

Mechanism of action

Pharmacodynamics and immunogenicity: NCT02224820

Phase 1 study in healthy subjects: NCT01802697

Imlifidase-generated single-cleaved IgG

F(ab′)2 fragments and complement activation: in vitro study

Anti-IdeS antibodies in healthy humans

Pharmacokinetics

Product information: pharmacokinetic parameters

Serious adverse reactions

Selected contraindications

Identified risks and infection prevention

Interference with alloantibody screening: case report

Interference with protein electrophoresis and immunofixation

Hepatic impairment and pediatric populations

Drug interactions

Neutralizing antibodies in intravenous immunoglobulin preparations

Potential impairment of alemtuzumab activity after imlifidase

Dose

Route and infusion duration

Premedication

Hospital restriction

European and MENA rights acquired by SERB

French consensus protocol: accompanying immunosuppression

Welsh commissioning requirements for quality monitoring

Demonstrated effect on quality-measure performance

ConfIdeS: randomized comparison of kidney function at 12 months

Kidney failure

Sensitization risk factors

HLA sensitization

Transplant-waiting-list population

Transplant access and unmet need: background studies

Waiting time and mortality risk

Antibody-mediated effector activity

International Delphi consensus on imlifidase desensitization

Fluid retention: manifestations of kidney failure

Fatigue and sleep disturbance: manifestations of kidney failure

Cardiovascular burden in kidney disease

Mineral and bone disorder in chronic kidney disease

Humanistic burden

Irish economic model: utility-data limitation

In-center hemodialysis: treatment frequency and duration

Irish economic model: probabilistic sensitivity analysis

Background evidence: caregivers of children with chronic kidney disease in Egypt

Costs borne by families of highly sensitized adult transplant candidates

French selection pathway: cost implications of diluted-serum HLA testing

European guidance on acceptable mismatch programs

Belgian consensus: Acceptable Mismatch program

European Society for Organ Transplantation guideline

Existing desensitization approaches

Guideline-supported antibody removal with adjunctive therapy

European consensus: first-line desensitization

European consensus: adjunctive prevention of antibody rebound

French consensus guidelines: patient selection

European Delphi consensus on sensitized kidney-transplant recipients

Selected agents in the French imlifidase-enabled transplantation protocol

Dialysis modalities for kidney failure

Summary

Conventional desensitization: treatment duration and incomplete response

German expert consensus: evidence limitations

Summary

Baseline donor-specific antibodies and early rejection risk

German expert consensus: biopsy surveillance

Sponsor-reported agreement on follow-up in the proposed accelerated approval pathway

European conditional authorization: long-term effectiveness follow-up

Company-reported completion of the post-authorization efficacy study obligation