Five abstracts underscore the long-term safety
and efficacy of voclosporin, including in Latino patients and
patients with Class V lupus nephritis
Data presentation on pre-clinical asset AUR200
reinforces Aurinia’s commitment to autoimmune disease
Aurinia Pharmaceuticals Inc. (NASDAQ:AUPH) (Aurinia or the
Company), a biopharmaceutical company committed to delivering
therapeutics that change the trajectory of autoimmune disease,
today announced that data from multiple studies of LUPKYNIS®
(voclosporin), used to treat adults with active lupus nephritis
(LN), a serious complication of systemic lupus erythematosus (SLE),
will be presented at American College of Rheumatology (ACR)
Convergence 2022. ACR Convergence 2022 will take place November
10-14 at the Pennsylvania Convention Center in Philadelphia,
Pennsylvania.
The abstracts for ACR Convergence 2022 are listed below and
available online at:
https://acrabstracts.org/meetings/acr-convergence-2022/.
ACR Convergence 2022 Oral and Poster
Presentations:
Title: Long-term Use of Voclosporin in Patients with
Class V Lupus Nephritis: Results from the AURORA 2 Continuation
Study Presenting author: Amit Saxena, M.D., Assistant
Professor, Department of Medicine NYU Grossman School of Medicine
Date: Saturday, November 12, 2022 Time: 1:00 p.m -
3:00 p.m ET Session: SLE-Treatment Poster I, Abstract
0355
Title: Early Reductions in Proteinuria with Voclosporin
Treatment Across Lupus Nephritis Biopsy Classes: Pooled Data from
the AURA-LV and AURORA 1 Trials Presenting author: Anca
Askanase, M.D., M.P.H., Professor of Medicine, Columbia University
Irving Medical Center, Department of Rheumatology Date:
Saturday, November 12, 2022 Time: 1:00 p.m - 3:00 p.m ET
Session: SLE-Treatment Poster I, Abstract 0356
Title: Voclosporin Is Effective in Achieving Proteinuria
Treatment Targets in Lupus Nephritis Defined by EULAR/ERA
Recommendations Presenting author: Hans-Joachim Anders,
M.D., Professor of Nephrology and Head of Renal Division,
University of Munich (LMU) Date: Saturday, November 12, 2022
Time: 1:00 p.m - 3:00 p.m ET Session: SLE-Treatment
Poster I, Abstract 0357
Title: Long-term Safety and Efficacy of Voclosporin in
Hispanic and Latino Patients with Lupus Nephritis Presenting
author: Ellen M. Ginzler, M.D., M.P.H., Vice Chair for
Research, Department of Medicine Chief, Rheumatology Division, SUNY
Downstate Health Science University Date: Saturday, November
12, 2022 Time: 1:00 p.m - 3:00 p.m ET Session:
SLE-Treatment Poster I, Abstract 0358
Title: AUR200: An Improved BAFF/APRIL Inhibitor with
Increased Potency and Safety for the Treatment of B Cell-Mediated
Diseases Presenting author: Shawn Morales, Ph.D., Aurinia
Pharmaceuticals Date: Monday, November 14, 2022 Time:
9:00 a.m - 10:00 a.m ET Session: Abstracts: B Cell Biology
and Targets in Autoimmune and Inflammatory Disease, Abstract
1629
Title: Voclosporin for Lupus Nephritis: Assessment of
Long-Term Safety and Efficacy Including Renal Outcome over Three
Years of Treatment in the Phase 3 AURORA 1 and AURORA 2 Studies
Presenting author: Cristina Arriens, M.D., Clinical
Assistant Member, Oklahoma Medical Research Foundation Date:
Monday, November 14, 2022 Time: 9:00 a.m - 10:30 a.m ET
Session: Abstracts: SLE-Treatment, Abstract 1653
About Lupus Nephritis LN is a serious manifestation of
SLE, a chronic and complex autoimmune disease. About
200,000-300,000 people live with SLE in the U.S. and about
one-third of these people are diagnosed with lupus nephritis at the
time of their SLE diagnosis. About 50 percent of all people with
SLE may develop lupus nephritis. If poorly controlled, LN can lead
to permanent and irreversible tissue damage within the kidney.
Black and Asian individuals with SLE are four times more likely to
develop LN and individuals of Hispanic ancestry are approximately
twice as likely to develop the disease when compared with Caucasian
individuals. Black and Hispanic individuals with SLE also tend to
develop LN earlier and have poorer outcomes when compared to
Caucasian individuals.
About LUPKYNIS LUPKYNIS® is the first U.S. FDA- and
EC-approved oral medicine for the treatment of adult patients with
active lupus nephritis (LN). LUPKYNIS is a novel, structurally
modified 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 recommended starting dose of LUPKYNIS is three
capsules twice daily with no requirement for serum drug monitoring.
Dose modifications can be made based on Aurinia’s proprietary
personalized eGFR-based dosing protocol. Boxed Warning, warnings,
and precautions for LUPKYNIS are consistent with those of other
CNI-immunosuppressive treatments.
About Aurinia Aurinia Pharmaceuticals is a fully
integrated biopharmaceutical company focused on delivering
therapies to treat targeted patient populations that are impacted
by serious diseases with a high unmet medical need. In January
2021, the Company introduced LUPKYNIS® (voclosporin), the first
FDA-approved oral therapy dedicated for the treatment of adult
patients with active lupus nephritis. The Company’s head office is
in Victoria, British Columbia, its U.S. commercial office is in
Rockville, Maryland. The Company focuses its development efforts
globally.
INDICATION AND IMPORTANT SAFETY INFORMATION
INDICATIONS
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), which
may lead to serious, including fatal, outcomes.
Nephrotoxicity: LUPKYNIS, like other CNIs, may cause acute
and/or chronic nephrotoxicity. The risk is increased when CNIs are
concomitantly administered with drugs associated with
nephrotoxicity.
Hypertension: Hypertension is a common adverse reaction of
LUPKYNIS therapy and may require antihypertensive therapy.
Neurotoxicity: LUPKYNIS, like other CNIs, may cause a spectrum
of neurotoxicities: severe include posterior reversible
encephalopathy syndrome (PRES), delirium, seizure, and coma; others
include tremor, paresthesia, headache, and changes in mental status
and/or motor and sensory functions.
Hyperkalemia: Hyperkalemia, which may be serious and require
treatment, has been reported with CNIs, including LUPKYNIS.
Concomitant use of agents associated with hyperkalemia may increase
the risk for hyperkalemia.
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 (PRCA)
have been reported in patients treated with another CNI
immunosuppressant. If PRCA is diagnosed, consider discontinuation
of LUPKYNIS.
Drug-Drug Interactions: Avoid co-administration of LUPKYNIS and
strong CYP3A4 inhibitors or with strong or moderate CYP3A4
inducers. Reduce LUPKYNIS dosage when co-administered with moderate
CYP3A4 inhibitors. Reduce dosage of certain P-gp substrates with
narrow therapeutic windows when co-administered.
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, mouth
ulceration, fatigue, tremor, acute kidney injury, and decreased
appetite.
SPECIFIC POPULATIONS
Pregnancy/Lactation: May cause fetal harm. Advise not to
breastfeed.
Renal Impairment: Not recommended in patients with baseline eGFR
≤45 mL/min/1.73 m2 unless benefit exceeds risk. Severe renal
impairment: Reduce LUPKYNIS dose.
Mild and Moderate Hepatic Impairment: Reduce LUPKYNIS dose.
Severe hepatic impairment: Avoid LUPKYNIS use.
Please see Prescribing Information, including Boxed Warning, and
Medication Guide for LUPKYNIS.
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version on businesswire.com: https://www.businesswire.com/news/home/20220920006147/en/
Investors DeDe Sheel dsheel@auriniapharma.com
Media aurinia@healthandcommerce.com
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