TAVNEOS was studied in a clinical trial involving 330 ANCA-associated vasculitis patients (GPA and MPA only) over 52 weeks1,2

The efficacy and safety of TAVNEOS as an adjunctive treatment were evaluated in the ADVOCATE trial1,2

While substituting ~2.5 g of oral prednisone with TAVNEOS, the goal of the ADVOCATE trial was to evaluate if patients with ANCA-associated vasculitis could2,3:

  • Achieve comparable remission to prednisone at
    Week 262,3
  • Achieve superior sustained remission to prednisone
    at Week 522,3
  • Demonstrate efficacy in additional measurements2,3

TAVNEOS approval is based on 12-month continuous dosing1,2

The ADVOCATE trial was a phase 3, randomized, double-blind, double-dummy, active-controlled trial in 330 patients with newly diagnosed or relapsing ANCA-associated vasculitis1,2

Charing showing The ADVOCATE trial design

*MMF could be used if AZA was contraindicated.1

Depending on route of administration—13 weeks for IV CYC and 14 weeks for oral CYC.

AZA, azathioprine; CYC, cyclophosphamide; IV, intravenous; MMF, mycophenolate mofetil; RTX, rituximab.

Patients were stratified at time of randomization to obtain balance across treatment groups based on 3 factors2:

Number one icon

Newly diagnosed or relapsing
ANCA-associated vasculitis

Number two icon

Proteinase 3 positive or
myeloperoxidase positive
ANCA-associated vasculitis

Number three icon

Receiving either IV CYC,
oral CYC, or IV RTX

  • Additional non-study supplied glucocorticoids were allowed as pre-medication for rituximab to reduce hypersensitivity reactions, taper after glucocorticoids given during the screening period, treatment of persistent vasculitis, worsening of vasculitis, or relapses, as well as for non-vasculitis reasons such as adrenal insufficiency1,3
    • The incidence of this additional glucocorticoid exposure was balanced between both groups2,3
  • Remission is defined as achieving a Birmingham Vasculitis Activity Score (BVAS) of 0 and not taking glucocorticoids for treatment of ANCA-associated vasculitis within 4 weeks prior to Week 261
  • Sustained remission is defined as remission at Week 26 without relapse to Week 52 (BVAS of 0 and not taking glucocorticoids for treatment of ANCA-associated vasculitis within 4 weeks prior to Week 52)1
  • Relapse was defined as occurrence of 1 major item, at least 3 non-major items, or 1 or 2 non-major items for at least 2 consecutive visits on the BVAS after remission (BVAS of 0) had been achieved1
TAVNEOS and
prednisone groups
were well balanced
regarding baseline
demographics and
disease characteristics.1
  • Mean patient age was 60.9 years1
  • Most patients were male (56.4%) and had newly diagnosed disease (69.4%)1
  • Patients had either GPA (54.8%) or MPA (45.2%) and had presence
    of anti-PR3 (43.0%) or anti-MPO (57.0%) antibodies1
  • Mean baseline BVAS was 16.2, and patients most commonly had
    manifestations within1:
    • Renal component (81.2%)
    • General component (68.2%)
    • Ear/nose/throat component (43.6%)
    • Chest component (43.0%)
  • Immunosuppressant induction treatment for patients:
    • Approximately 65% received rituximab1
    • 31% received IV cyclophosphamide1
    • 4% received oral cyclophosphamide1
  • In the prednisone arm, patients were given 60 mg prednisone per day tapered to discontinuation by Week 212
The ChemoCentryx commitment to ANCA-associated vasculitis treatment is strong, with over 20 years of research and development
Building icon
1997    ChemoCentryx was founded
Calendar icon
2006    Birth of the TAVNEOS (avacopan) project
Report icon
2016    TAVNEOS (avacopan) phase 2 data in ANCA-associated vasculitis
Pencil icon
2017    Initiation of TAVNEOS (avacopan) pivotal phase 3
ADVOCATE
trial in ANCA-associated vasculitis
Lightbulb icon
2019    Positive top-line data from phase 3 ADVOCATE trial present path to commercialization
Folder icon
2020    NDA filing for TAVNEOS (avacopan) in ANCA-associated vasculitis
Article icon
2021
New England Journal of Medicine publishes results
from TAVNEOS (avacopan) clinical trials2
TAVNEOS (avacopan) approval1
NEXT: Efficacy Data »

INDICATION

TAVNEOS (avacopan) is indicated as an adjunctive treatment of adult patients with severe active anti-neutrophil cytoplasmic autoantibody (ANCA)-associated vasculitis (granulomatosis with polyangiitis [GPA] and microscopic polyangiitis [MPA]) in combination with standard therapy including glucocorticoids. TAVNEOS does not eliminate glucocorticoid use.

Important Safety Information

CONTRAINDICATIONs

Serious hypersensitivity to avacopan or to any of the excipients.

WARNINGS AND PRECAUTIONS

Hepatotoxicity: Serious cases of hepatic injury have been observed in patients taking TAVNEOS, including life-threatening events. Obtain liver test panel before initiating TAVNEOS, every 4 weeks after start of therapy for 6 months and as clinically indicated thereafter. Monitor patients closely for hepatic adverse reactions, and consider pausing or discontinuing treatment as clinically indicated (refer to section 5.1 of the Prescribing Information). TAVNEOS is not recommended for patients with active, untreated, and/or uncontrolled chronic liver disease (e.g., chronic active hepatitis B, untreated hepatitis C, uncontrolled autoimmune hepatitis) and cirrhosis. Consider the risks and benefits before administering this drug to a patient with liver disease.

Serious Hypersensitivity Reactions: Cases of angioedema occurred in a clinical trial, including 1 serious event requiring hospitalization. Discontinue immediately if angioedema occurs and manage accordingly. TAVNEOS must not be readministered unless another cause has been established.

Hepatitis B Virus (HBV) Reactivation: Hepatitis B reactivation, including life-threatening hepatitis B, was observed in the clinical program. Screen patients for HBV. For patients with evidence of prior infection, consult with physicians with expertise in HBV and monitor during TAVNEOS therapy and for 6 months following. If patients develop HBV reactivation, immediately discontinue TAVNEOS and concomitant therapies associated with HBV reactivation, and consult with experts before resuming.

Serious Infections: Serious infections, including fatal infections, have been reported in patients receiving TAVNEOS. The most common serious infections reported in the TAVNEOS group were pneumonia and urinary tract infections. Avoid use of TAVNEOS in patients with active, serious infection, including localized infections. Consider the risks and benefits before initiating TAVNEOS in patients with chronic infection, at increased risk of infection, or who have been to places where certain infections are common.

ADVERSE REACTIONS

The most common adverse reactions (≥5% of patients and higher in the TAVNEOS group vs. prednisone group) were nausea, headache, hypertension, diarrhea, vomiting, rash, fatigue, upper abdominal pain, dizziness, blood creatinine increased, and paresthesia.

DRUG INTERACTIONS

Avoid coadministration of TAVNEOS with strong and moderate CYP3A4 enzyme inducers. Reduce TAVNEOS dose when coadministered with strong CYP3A4 enzyme inhibitors to 30 mg once daily. Monitor for adverse reactions and consider dose reduction of certain sensitive CYP3A4 substrates.

TAVNEOS is available as a 10 mg capsule.

Please see Full Prescribing Information and Medication Guide for TAVNEOS.

To report a suspected adverse event, call 1-833-828-6367. You may report to the FDA directly by visiting www.fda.gov/medwatch or calling 1-800-332-1088.

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS

Serious hypersensitivity to avacopan or to any of the excipients.

WARNINGS AND PRECAUTIONS

INDICATION

TAVNEOS (avacopan) is indicated as an adjunctive treatment of adult patients with severe active anti-neutrophil cytoplasmic autoantibody (ANCA)-associated vasculitis (granulomatosis with polyangiitis [GPA] and microscopic polyangiitis [MPA]) in combination with standard therapy including glucocorticoids. TAVNEOS does not eliminate glucocorticoid use.

INDICATION

TAVNEOS (avacopan) is indicated as an adjunctive treatment of adult patients with severe active anti-neutrophil cytoplasmic autoantibody (ANCA)-associated vasculitis (granulomatosis with polyangiitis [GPA] and microscopic polyangiitis [MPA]) in combination with standard therapy including glucocorticoids. TAVNEOS does not eliminate glucocorticoid use.

INDICATION

TAVNEOS (avacopan) is indicated as an adjunctive treatment of adult patients with severe active anti-neutrophil cytoplasmic autoantibody (ANCA)-associated vasculitis (granulomatosis with polyangiitis [GPA] and microscopic polyangiitis [MPA]) in combination with standard therapy including glucocorticoids. TAVNEOS does not eliminate glucocorticoid use.

Important Safety Information

CONTRAINDICATIONs

Serious hypersensitivity to avacopan or to any of the excipients.

WARNINGS AND PRECAUTIONS

Hepatotoxicity: Serious cases of hepatic injury have been observed in patients taking TAVNEOS, including life-threatening events. Obtain liver test panel before initiating TAVNEOS, every 4 weeks after start of therapy for 6 months and as clinically indicated thereafter. Monitor patients closely for hepatic adverse reactions, and consider pausing or discontinuing treatment as clinically indicated (refer to section 5.1 of the Prescribing Information). TAVNEOS is not recommended for patients with active, untreated, and/or uncontrolled chronic liver disease (e.g., chronic active hepatitis B, untreated hepatitis C, uncontrolled autoimmune hepatitis) and cirrhosis. Consider the risks and benefits before administering this drug to a patient with liver disease.

Serious Hypersensitivity Reactions: Cases of angioedema occurred in a clinical trial, including 1 serious event requiring hospitalization. Discontinue immediately if angioedema occurs and manage accordingly. TAVNEOS must not be readministered unless another cause has been established.

Hepatitis B Virus (HBV) Reactivation: Hepatitis B reactivation, including life-threatening hepatitis B, was observed in the clinical program. Screen patients for HBV. For patients with evidence of prior infection, consult with physicians with expertise in HBV and monitor during TAVNEOS therapy and for 6 months following. If patients develop HBV reactivation, immediately discontinue TAVNEOS and concomitant therapies associated with HBV reactivation, and consult with experts before resuming.

Serious Infections: Serious infections, including fatal infections, have been reported in patients receiving TAVNEOS. The most common serious infections reported in the TAVNEOS group were pneumonia and urinary tract infections. Avoid use of TAVNEOS in patients with active, serious infection, including localized infections. Consider the risks and benefits before initiating TAVNEOS in patients with chronic infection, at increased risk of infection, or who have been to places where certain infections are common.

ADVERSE REACTIONS

The most common adverse reactions (≥5% of patients and higher in the TAVNEOS group vs. prednisone group) were nausea, headache, hypertension, diarrhea, vomiting, rash, fatigue, upper abdominal pain, dizziness, blood creatinine increased, and paresthesia.

DRUG INTERACTIONS

Avoid coadministration of TAVNEOS with strong and moderate CYP3A4 enzyme inducers. Reduce TAVNEOS dose when coadministered with strong CYP3A4 enzyme inhibitors to 30 mg once daily. Monitor for adverse reactions and consider dose reduction of certain sensitive CYP3A4 substrates.

TAVNEOS is available as a 10 mg capsule.

Please see Full Prescribing Information and Medication Guide for TAVNEOS.

To report a suspected adverse event, call 1-833-828-6367. You may report to the FDA directly by visiting www.fda.gov/medwatch or calling 1-800-332-1088.

References: 1. TAVNEOS® (avacopan) Prescribing Information. ChemoCentryx, Inc. 2. Jayne DRW, Merkel PA, Schall TJ, Bekker P, for the ADVOCATE Study Group. Avacopan for the treatment of ANCA-associated vasculitis. N Engl J Med. 2021;384(7):599-609. doi:10.1056/NEJMoa2023386 3. Data on File, ChemoCentryx, Inc.