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IQIRVO efficacy1

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The only pivotal study for PBC in which

40% of patients had baseline ALP >3 x ULN2

The ELATIVE® trial was a double-blind, randomized, placebo-controlled study to evaluate the efficacy and safety of IQIRVO in patients with PBC and inadequate response or intolerance to UDCA.1

    ELATIVE study design
    • Placebo + UDCA referred to as “UDCA alone”
    • 95% (153/161) of patients on IQIRVO in the ELATIVE trial received concurrent UDCA therapy1
    • ULN for ALP was defined as 104 U/L for women and 129 U/L for men1
    ELATIVE trial design schematic desktop ELATIVE trial design schematic mobile

    Baseline characteristics2

    IQIRVO + UDCA
    (n=108)

    UDCA alone
    (n=53) 

    OLE crossovera
    (n=45)

    Sex, female %

    94

    98

    98

    Age <65 years %

    76.9

    81.1

     

    Years since 
    diagnosis (±SD)

    7.9 
    (5.9)

    8.3 
    (6.8)

    9.5 
    (6.6)

    Mean (±SD) 
    baseline ALP U/L

    321.3 (121.9)

    323.1 (198.6)

    335.8 (187.9)

    ALP >3 x ULN %

    39.8

    37.7

    42.2

    Mean (±SD) baseline total bilirubin mg/dL

    0.57 
    (0.30)

    0.55 
    (0.29)

    0.64 
    (0.53)

    Mean PBC WI-NRS score

    3.3

    3.2

     

    Mean liver stiffness kPa

    9.9

    10.7

     

    Liver stiffness 
    >10 kPa and/or 
    bridging fibrosis or 
    cirrhosis on histology 
    %

    34

    38

    31

    Osteoporosis %

    19

    4

     

    ~41% of patients had moderate-to-severe pruritus3

     

    ~35% started the trial with advanced disease2,3,b

    First second-line PBC treatment in which 13x more patients achieved biochemical response vs UDCA alone1

    Biochemical response at 52 weeks1:

    Blue IQIRVO checkmark icon

    ALP <1.67 x ULN

    Blue IQIRVO checkmark icon

    ALP decrease ≥15% from baseline

    Blue IQIRVO checkmark icon

    Total bilirubin ≤ ULN

    cSix patients in the IQIRVO group took IQIRVO alone, while 2 patients in the UDCA group took placebo alone.1

    dALP values are based on a weighted average of the ULN; 105 U/L is the weighted ULN based on a ULN of 129 U/L for men and 104 U/L for women.1

    Biochemical response at week 521,c

    51% biochemical response achieved with IQIRVO vs 4% with UDCA. Mean ALP decrease from 321 U/L at baseline to 175 U/L or lower (1.67 x ULN)—a mean reduction of 146 U/L 51% biochemical response achieved with IQIRVO vs 4% with UDCA. Mean ALP decrease from 321 U/L at baseline to 175 U/L or lower (1.67 x ULN)—a mean reduction of 146 U/L 51% biochemical response achieved with IQIRVO vs 4% with UDCA. Mean ALP decrease from 321 U/L at baseline to 175 U/L or lower (1.67 x ULN)—a mean reduction of 146 U/L 51% biochemical response achieved with IQIRVO vs 4% with UDCA. Mean ALP decrease from 321 U/L at baseline to 175 U/L or lower (1.67 x ULN)—a mean reduction of 146 U/L

    cSix patients in the IQIRVO group took IQIRVO alone, while 2 patients in the UDCA group took placebo alone.1

    dALP values are based on a weighted average of the ULN; 105 U/L is the weighted ULN based on a ULN of 129 U/L for men and 104 U/L for women.1

    Biochemical response across all subgroups2

    Patients achieving biochemical response in a 
    subgroup analysis by baseline ALP2

    Bar chart showing percentage of patients taking IQIRVO that saw biochemical response in a subgroup analysis Bar chart showing percentage of patients taking IQIRVO that saw biochemical response in a subgroup analysis

    Rapid ALP reduction as early as 4 weeks, sustained over 3 years2

    ALP reduction from baseline2

    Line chart showing ALP reduction from baseline Line chart showing ALP reduction from baseline Line chart showing ALP reduction from baseline

    37% reduction in ALP 
    as early as 4 weeks with IQIRVO2

    37% reduction in ALP 
    as early as 4 weeks with IQIRVO2

    ALP reduction across subgroups Powerful ALP reduction, regardless of starting point2

    Mean change from baseline to week 52 in ALP, 
    stratified by baseline ALP levels2

    Bar chart showing mean change from baseline to week 52 in ALP levels, stratified by baseline ALP levels Bar chart showing mean change from baseline to week 52 in ALP levels, stratified by baseline ALP levels

    A 22x greater reduction in ALP with IQIRVO vs UDCA alone3

    LS mean change from baseline: IQIRVO -117 U/L, UDCA -5.3 U/L3

    Unlock ALP normalization—only with IQIRVO1

    Bar chart showing ALP normalization at week 52 achieved with IQIRVO vs UDCA alone Bar chart showing ALP normalization at week 52 achieved with IQIRVO vs UDCA alone
    53% icon

    More than half of patients with baseline ALP ≤2 x ULN achieved normalization2

    Explore patient profiles

    Helen age 42

    Inadequate response to first-line treatment

    Disease history

    • 24 months since diagnosis
    • Treated with UDCA (900 mg daily) for 24 months
    • Current ALP 218 U/L (2.1 x ULN) vs 353 U/L (3.4 x ULN) at diagnosis4
    • 220 U/L ALP at 6-month marker vs 240 U/L at 12 months after starting therapy
    • Current bilirubin 0.56 mg/dL (normal) vs 0.56 mg/dL (normal) at diagnosis5

    Risk factors for progression

    • Inadequate response to first-line treatment6
    • Age <45 at diagnosis6,7

    ALP levels with first-line treatment

    Line chart showing ALP levels with first-line treatment Line chart showing ALP levels with first-line treatment

    With IQIRVO, 15% of patients were able to achieve ALP normalization of 105 U/L or lower. Lowering ALP is a key treatment goal in managing PBC1,8,d

    dALP values are based on a weighted average of the ULN; 105 U/L is the weighted ULN based on a ULN of 129 U/L for men and 104 U/L for women.1

    Marie age 57

    Unresponsive to current second-line treatment

    Disease history

    • 5 years since diagnosis
    • Second-line treatment added 6 months ago, in combination with UDCA (prescribed at diagnosis)
      • 5 years (UDCA), 1.5 years (UDCA + obeticholic acid)
    • Recently reported symptoms of increased pruritus and fatigue
    • Current ALP of 239 U/L (2.3 x ULN) vs 187 U/L (1.8 x ULN) at diagnosis4

    IQIRVO could help patients like Marie achieve biochemical response1

    Discover data on reduction of pruritus and fatigue with IQIRVO2,3

    aPatients completing the ELATIVE double-blind period were eligible to enter the OLE trial to receive IQIRVO 80 mg daily. Baseline in this OLE crossover arm was defined as the last available measurement before the first OLE IQIRVO dose.2

    bLiver stiffness >10 kPa and/or bridging fibrosis or cirrhosis on histology.2

    ALP=alkaline phosphatase; CI=confidence interval; OLE=open-label extension; PBC=primary biliary cholangitis; SD=standard deviation; SE=standard error; UDCA=ursodeoxycholic acid; ULN=upper limit of normal; WI-NRS=worst itch numeric rating scale.

    References: 1. IQIRVO [package insert]. Ipsen Biopharmaceuticals, Inc. Cambridge, MA. 2. Data on file. Ipsen Biopharmaceuticals, Inc. 3. Kowdley KV, Bowlus CL, Levy C, et al; ELATIVE Study Investigators’ Group. Efficacy and safety of elafibranor in primary biliary cholangitis. N Engl J Med. 2024;390(9):795-805, suppl. 4. ALKP. Mayo Clinic Laboratories. Accessed February 6, 2025. https://www.mayocliniclabs.com/test-catalog/overview/622157#Clinical-and-Interpretive. 5. BILI3. Mayo Clinic Laboratories. Accessed February 6, 2025. https://www.mayocliniclabs.com/test-catalog/overview/8452#Clinical-and-Interpretive. 6. Hirschfield GM, Chazouillères O, Cortez-Pinto H, et al. A consensus integrated care pathway for patients with primary biliary cholangitis: a guideline-based approach to clinical care of patients. Expert Rev Gastroenterol Hepatol. 2021;15(8):929-939. 7. European Association for the Study of the Liver. EASL Clinical Practice Guidelines: the diagnosis and management of patients with primary biliary cholangitis. J Hepatol. 2017;67(1):145-172. 8. Kowdley KV, Bowlus CL, Levy C, et al. Application of the latest advances in evidence-based medicine in primary biliary cholangitis. Am J Gastroenterol. 2023;118(2):232-242.

    Indication and Important Safety Information

    Indication

    IQIRVO® is indicated for the treatment of primary biliary cholangitis (PBC) in combination with ursodeoxycholic acid (UDCA) in adults with an inadequate response to UDCA, or as monotherapy in adults unable to tolerate UDCA.

    This indication is approved under accelerated approval based on reduction of alkaline phosphatase (ALP). Improvement in survival or prevention of liver decompensation events have not been demonstrated. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s).

    Limitations of Use

    Use of IQIRVO is not recommended in patients who have or develop decompensated cirrhosis (e.g., ascites, variceal bleeding, hepatic encephalopathy).

    Important Safety Information

    Myalgia, Myopathy, and Rhabdomyolysis: Rhabdomyolysis resulting in acute kidney injury occurred in one IQIRVO-treated patient who had cirrhosis at baseline and was also taking a stable dose of an HMG-CoA reductase inhibitor (statin). Myalgia or myopathy, with or without CPK elevations, occurred in patients treated with IQIRVO alone or treated concomitantly with a stable dose of an HMG-CoA reductase inhibitor. Assess for myalgia and myopathy prior to IQIRVO initiation. Consider periodic assessment (clinical exam, CPK measurement) during treatment with IQIRVO, especially in those who have signs and symptoms of new onset or worsening of muscle pain or myopathy. Interrupt IQIRVO treatment if there is new onset or worsening of muscle pain, or myopathy, or rhabdomyolysis.

    Fractures: Fractures occurred in 6% of IQIRVO-treated patients compared to no placebo-treated patients. Consider the risk of fracture in the care of patients treated with IQIRVO and monitor bone health according to current standards of care.

    Adverse Effects on Fetal and Newborn Development: IQIRVO may cause fetal harm when administered during pregnancy. For females of reproductive potential, verify that the patient is not pregnant prior to initiation of therapy. Advise females of reproductive potential to use effective non-hormonal contraceptives or add a barrier method when using systemic hormonal contraceptives during treatment with IQIRVO and for 3 weeks following the last dose of IQIRVO.

    Drug-Induced Liver Injury: Drug-induced liver injury occurred in one patient who took IQIRVO 80 mg once daily and two patients who took IQIRVO at 1.5-times the recommended dosage, of which one presented with autoimmune-like hepatitis. The median time to onset of elevation in liver tests was 85 days. Obtain baseline clinical and laboratory assessments at treatment initiation with IQIRVO and monitor thereafter according to routine patient management. Interrupt IQIRVO treatment if liver tests (ALT, AST, total bilirubin [TB], and/or alkaline phosphatase [ALP]) worsen, or the patient develops signs and symptoms consistent with clinical hepatitis (e.g., jaundice, right upper quadrant pain, eosinophilia). Consider permanent discontinuation if liver tests worsen after restarting IQIRVO.

    Hypersensitivity Reactions: Hypersensitivity reactions have occurred in a clinical trial with IQIRVO at 1.5-times the recommended dosage. Three patients (0.2%) had rash or unspecified allergic reaction that occurred 2 to 30 days after IQIRVO initiation. Hypersensitivity reactions resolved after discontinuation of IQIRVO and treatment with steroids and/or antihistamines. If a severe hypersensitivity reaction occurs, permanently discontinue IQIRVO. If a mild or moderate hypersensitivity reaction occurs, interrupt IQIRVO and treat promptly. Monitor the patient until signs and symptoms resolve. If a hypersensitivity reaction recurs after IQIRVO rechallenge, then permanently discontinue IQIRVO.

    Biliary Obstruction: Avoid use of IQIRVO in patients with complete biliary obstruction. If biliary obstruction is suspected, interrupt IQIRVO and treat as clinically indicated.

    Drug-Drug Interactions

    IQIRVO may reduce the systemic exposure of progestin and ethinyl estradiol (CYP3A4 substrates), which may lead to contraceptive failure and/or an increase in breakthrough bleeding. Switch to effective non-hormonal contraceptives or add a barrier method when using hormonal contraceptives during treatment with IQIRVO and for at least 3 weeks after last dose.

    CPK elevation and/or myalgia occurred in patients on IQIRVO monotherapy. Co-administration of IQIRVO and HMG-CoA reductase inhibitors can increase the risk of myopathy. Monitor for signs and symptoms of muscle injury. Consider periodic assessment (clinical exam, CPK) during treatment. Interrupt IQIRVO treatment if there is new onset or worsening of muscle pain or myopathy.

    Co-administration of IQIRVO with rifampin, an inducer of metabolizing enzymes, may reduce the systemic exposure of elafibranor resulting in delayed or suboptimal biochemical response. Monitor the biochemical response (e.g., ALP and bilirubin) when patients initiate rifampin during treatment with IQIRVO.

    Bile acid sequestrants may interfere with IQIRVO absorption and systemic exposure, which may reduce efficacy. Administer IQIRVO at least 4 hours before or after a bile acid sequestrant, or at as great an interval as possible.

    Use in Special Populations

    Pregnancy: Based on data from animal reproduction studies, IQIRVO may cause fetal harm when administered during pregnancy. There are insufficient data from human pregnancies exposed to IQIRVO to allow an assessment of a drug-associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes. Report pregnancies to Ipsen Biopharmaceuticals, Inc. adverse event reporting line at 1-855-463-5127 or https://www.ipsen.com/contact-us/.

    Lactation: There are no data available on the presence of IQIRVO or its metabolites in human milk, or on effects of the drug on the breastfed infant or the effects on milk production. IQIRVO is not recommended during breastfeeding and for at least 3 weeks following last dose of IQIRVO because the risk to breastfed child cannot be excluded.

    Females and Males of Reproductive Potential: IQIRVO may cause fetal harm when administered to pregnant women. Verify the pregnancy status of females of reproductive potential prior to initiating IQIRVO. Advise females of reproductive potential to use effective contraception during treatment with IQIRVO and for 3 weeks after the final dose.

    The most common adverse events occurring in ≥10% of patients were weight gain (23%), abdominal pain (11%), nausea (11%), vomiting (11%), and diarrhea (11%).

    You are encouraged to report side effects to FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. You may also report side effects to Ipsen Biopharmaceuticals, Inc. at 1-855-463-5127.

    Please see full Prescribing Information for IQIRVO.