Aurinia Pharmaceuticals Inc. (NASDAQ: AUPH) (Aurinia or the
Company), today announced an oral presentation at the European
Alliance of Associations for Rheumatology (EULAR) 2024 taking place
in Vienna, Austria June 12-15. The data reinforces previous
findings from the AURORA Clinical Program on the safety and
effectiveness of LUPKYNIS® (voclosporin), a second generation
calcineurin inhibitor (CNI), for the treatment of adult patients
with active lupus nephritis (LN).
A propensity analysis comparing the pooled AURA-LV and AURORA 1
studies to the Aspreva Lupus Management Study (ALMS) suggested that
a triple immunosuppressive therapy regimen of LUPKYNIS plus
lower-dose MMF and low-dose steroids (≤2 g/day) resulted in earlier
and greater reductions in proteinuria, reduced cumulative steroid
exposure, and demonstrated comparable rates of overall adverse
events, compared to dual immunosuppressive therapy regimens
combining high-dose glucocorticoids with either higher doses of MMF
or cyclophosphamide.
Safety and efficacy outcomes for propensity-matched patients
with active LN from ALMS and AURA-LV/AURORA 1 were assessed at
three and six months. Patients who received the LUPKYNIS-based
regimen showed >50% reduction in steroid exposure at six months
and more frequently achieved a urine protein creatinine ratio
(UPCR) of <0.5 mg/mg in a faster
median time as compared to the high-dose two drug regimen. These
patients also achieved >50% UPCR reduction at any time point in
the study significantly earlier than their propensity-matched
counterparts in ALMS. These findings support guideline
recommendations that LUPKYNIS plus lower-dose MMF and low-dose
steroids should be considered as an initial therapy in patients
with active LN.
Results from this study were also recently presented at the
annual European Renal Association Congress 2024.
About Lupus Nephritis
Lupus nephritis (LN) is a serious manifestation of systemic
lupus erythematosus (SLE), a chronic and complex autoimmune
disease. LN affects approximately 120,000 people in the U.S. and
disproportionately affects women and people of color. People living
with LN have high unmet needs and often face significant barriers
to optimal care. If poorly controlled, LN can lead to permanent and
irreversible tissue damage within the kidney. Medical guidelines
recommend that all SLE patients receive routine LN screenings at
every visit. Guidelines also note that delaying LN diagnosis has
profound prognostic repercussions. Yet, research shows that
approximately 50% of SLE patients are not screened for LN and 77%
of people with LN go untreated. Aurinia is committed to improving
health outcomes for people living with LN by educating patients and
providers on the critical need for routine screening and
transformative therapies that can help improve health outcomes.
About LUPKYNIS
LUPKYNIS (voclosporin) is the first U.S. Food and Drug
Administration and European Commission approved oral medicine for
the treatment of adult patients with active lupus nephritis (LN).
LUPKYNIS is a second generation calcineurin inhibitor (CNI) with a
dual mechanism of action, acting as an immunosuppressant through
inhibition of T-cell activation and cytokine production and
promoting podocyte stability in the kidney. The AURORA Clinical
Program, comprised of the AURORA 1 pivotal trial and AURORA 2
extension trial, demonstrated the importance of LUPKYNIS plus
standard of care to preserve kidney health in patients with active
LN without reliance on chronic high-dose glucocorticoids. It is the
only clinical program to include three years of LN treatment and
follow-up with mycophenolate mofetil (MMF) and steroids.
About Aurinia
Aurinia Pharmaceuticals is a fully integrated biopharmaceutical
company focused on delivering therapies to people living with
autoimmune diseases with high unmet medical needs. In January 2021,
the Company introduced LUPKYNIS (voclosporin), the first
FDA-approved oral therapy dedicated to the treatment of adult
patients with active lupus nephritis. The Company’s head office is
in Edmonton, Alberta, its U.S. commercial office is in Rockville,
Maryland. The Company focuses its development efforts globally.
INDICATION AND IMPORTANT SAFETY INFORMATION
INDICATION
LUPKYNIS is indicated in combination with a background
immunosuppressive therapy regimen for the treatment of adult
patients with active LN. Limitations of Use: Safety and efficacy of
LUPKYNIS have not been established in combination with
cyclophosphamide. Use of LUPKYNIS is not recommended in this
situation.
IMPORTANT SAFETY INFORMATION
BOXED WARNINGS: MALIGNANCIES AND SERIOUS INFECTIONS
Increased risk for developing malignancies and serious
infections with LUPKYNIS or other immunosuppressants that may lead
to hospitalization or death.
CONTRAINDICATIONS: LUPKYNIS is contraindicated in
patients taking strong CYP3A4 inhibitors because of the increased
risk of acute and/or chronic nephrotoxicity, and in patients who
have had a serious/severe hypersensitivity reaction to LUPKYNIS or
its excipients.
WARNINGS AND PRECAUTIONS
Lymphoma and Other Malignancies: Immunosuppressants,
including LUPKYNIS, increase the risk of developing lymphomas and
other malignancies, particularly of the skin. The risk appears to
be related to increasing doses and duration of immunosuppression
rather than to the use of any specific agent.
Serious Infections: Immunosuppressants, including
LUPKYNIS, increase the risk of developing bacterial, viral, fungal,
and protozoal infections, including opportunistic infections. This
may lead to serious, even fatal, outcomes.
Nephrotoxicity: LUPKYNIS, like other calcineurin
inhibitors (CNIs), may cause acute and/or chronic nephrotoxicity.
The risk is increased if administered with drugs associated with
nephrotoxicity. Monitor eGFR regularly.
Hypertension: Hypertension is a common adverse reaction
of LUPKYNIS therapy that may require antihypertensive therapy.
Monitor blood pressure regularly.
Neurotoxicity: LUPKYNIS, like other CNIs, may cause
neurotoxicities that if severe can include posterior reversible
encephalopathy syndrome, delirium, seizure, and coma; others
include tremor, paresthesia, headache, and changes in mental status
and/or motor and sensory functions. Monitor for neurologic
symptoms.
Hyperkalemia: Hyperkalemia, which may be serious and
require treatment, has been reported. Concomitant use of agents
associated with hyperkalemia may increase the risk for
hyperkalemia. Monitor serum potassium periodically.
QTc Prolongation: LUPKYNIS prolongs the QTc interval in a
dose-dependent manner when dosed higher than the recommended lupus
nephritis therapeutic dose. The use of LUPKYNIS in combination with
other drugs that are known to prolong QTc may result in clinically
significant QT prolongation.
Immunizations: Avoid the use of live attenuated vaccines
during treatment with LUPKYNIS. Inactivated vaccines noted to be
safe for administration may not be sufficiently immunogenic during
treatment with LUPKYNIS.
Pure Red Cell Aplasia: Cases of pure red cell aplasia
have been reported in patients treated with another CNI. If PRCA is
diagnosed, consider discontinuation of LUPKYNIS.
ADVERSE REACTIONS
The most common adverse reactions (>3%) were glomerular
filtration rate decreased, hypertension, diarrhea, headache,
anemia, cough, urinary tract infection, abdominal pain upper,
dyspepsia, alopecia, renal impairment, abdominal pain.
Drug-Drug Interactions: Avoid co-administration of
LUPKYNIS and strong CYP3A4 inhibitors or with strong or moderate
CYP3A4 inducers. Co-administration of LUPKYNIS with strong CYP3A4
inhibitors is contraindicated. Reduce LUPKYNIS dosage when
co-administered with moderate CYP3A4 inhibitors. Avoid use of
LUPKINS with strong or moderate CYP3A4 inducers.
SPECIFIC POPULATIONS
Pregnancy: Avoid use of LUPKYNIS.
Lactation: Consider the benefits and risks of LUPKYNIS
and possible risks to the fetus when prescribing LUPKYNIS to a
lactating woman.
Renal Impairment: LUPKYNIS is not recommended in patients
with baseline eGFR ≤45 mL/min/1.73 m2 unless benefit exceeds risk.
If used in this population, reduce LUPKYNIS dose.
Hepatic Impairment: For mild or moderate hepatic
impairment, reduce LUPKYNIS dose. Avoid use with severe hepatic
impairment.
Please see Prescribing Information, including Boxed Warning, and
Medication Guide for LUPKYNIS.
References
- Dall’Era M. et al. Comparison of a Voclosporin-based, Triple
Immunotherapy Regimen to High-dose Glucocorticoid-based
Immunosuppressive Therapy: A Propensity Analysis of the AURA-LV
plus AURORA 1 Studies and ALMS. Presented at the European Alliance
of Associations for Rheumatology, 2024, Vienna, Austria.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20240605563024/en/
Media and Investor Inquiries: Andrea Christopher
Corporate Communications & Investor Relations
achristopher@auriniapharma.com ir@auriniapharma.com
Aurinia Pharmaceuticals (NASDAQ:AUPH)
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