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 14 studies of LUPKYNIS®
(voclosporin) will be presented at the American Society of
Nephrology (ASN) Kidney Week 2023, taking place November 2-5 in
Philadelphia, Pennsylvania and at the 2023 American College of
Rheumatology Convergence (ACR), taking place November 10-15 in San
Diego, California.
Led by several leading experts in nephrology and rheumatology,
these presentations reinforce the long-term safety and efficacy
profile of LUPKYNIS® for the treatment of adults with active lupus
nephritis (LN), a serious complication of systemic lupus
erythematosus (SLE). The robust set of data demonstrates Aurinia’s
deep commitment to sustained research in autoimmune diseases,
including lupus.
The abstracts for ASN Kidney Week 2023 are listed below and
available online at:
https://www.asn-online.org/education/kidneyweek/2023/program-search-abstract.aspx
The abstracts for ACR 2023 are listed below and available online
at: https://acrabstracts.org/
Aurinia will issue full data press releases at the time of the
meetings.
ASN Kidney Week 2023 Oral and Poster
Presentations:
Title: Repeat kidney biopsies from
the AURORA 2 study of voclosporin in active lupus nephritis
Authors: Samir V. Parikh, Clint Abner, Ernie Yap, Krista
Piper, Rob Huizinga, Henry Leher Date: Thursday, November 2,
2023 Time: 5:42 p.m. – 5:51 p.m. ET Oral Session:
Glomerular Diseases - Clinical and Translational Studies
Location: Room 103
Title: Urinary extracellular
vesicles reveal distinct biological effects of voclosporin in the
treatment of lupus nephritis Authors: Martijn H. van
Heugten, Kuangyu Wei, Hester van Willigenburg, Faith Demir, Linda
M. Rehaume, John Viel, Markus M. Rinschen, Ewout J. Hoorn
Date: Thursday, November 2, 2023 Time: 10:00 a.m. –
12:00 p.m. ET Location: Poster Hall, #TH-PO550
Title: Registry of US adult
patients with lupus nephritis treated with LUPKYNIS for lupus
nephritis Authors: Lily Cipolla, Victoria Bal, Henry
Leher Date: Friday, November 3, 2023 Time: 10:00 a.m.
– 12:00 p.m. ET Location: Poster Hall, #INFO16-FR
Title: Voclosporin treatment in
adolescents with lupus nephritis (VOCAL) Authors:
Nicola Waddingham, Amber Rosales, Gigi Cheung, Blake Potter, Mary
Palmen (Presented by Ernie Yap) Date: Friday, November 3,
2023 Time: 10:00 a.m. – 12:00 p.m. ET Location:
Poster Hall, #INFO17-FR
Title: Long-term safety and
efficacy of voclosporin in Black patients with lupus
nephritis Authors: Gabriel Contreras, Matt Baker,
Lucy Hodge, Ernie Yap Date: Saturday, November 4, 2023
Time: 10:00 a.m. – 12:00 p.m. ET Location: Poster
Hall, #SA-PO876
Title: Comparison of
dual-immunosuppressive therapy and a voclosporin-based,
triple-immunosuppressive regimen for lupus nephritis: a propensity
analysis of ALMS and AURORA 1 studies Authors: Ernie
Yap, Maria Dall’Era, Matt Truman, Lucy S. Hodge, Neil Solomons
Date: Saturday, November 4, 2023 Time: 10:00 a.m. –
12:00 p.m. ET Location: Poster Hall, #SA-PO877
Title: Comparative effects of
cyclosporine and voclosporin on primary human proximal tubular
epithelial (PTEC) gene expression Authors: Theresa
Aliwarga, Linda M Rehaume, Catherine K Yeung, Jonathan Himmelfarb,
Edward J Kelly Date: Saturday, November 4, 2023 Time:
10:00 a.m. – 12:00 p.m. ET Location: Poster Hall,
#TH-PO103
Title: Voclosporin ameliorates both
proteinuria and dyslipidemia in a model of non-inflammatory
glomerular disease Authors: Yu Kamigaki, Julie
Dougherty, Amanda P. Waller, Linda M. Rehaume, Katelyn Wolfgang,
Eman Abdelghani, Bryce A. Kerlin, William E. Smoyer Date:
Saturday, November 4, 2023 Time: 10:00 a.m. – 12:00 p.m. ET
Location: Poster Hall, #SA-PO975
Title: Integrative systems analysis
of calcineurin inhibitor action on podocytes and proximal tubular
epithelial cells Authors: Anthony Mendoza, Kirk
Campbell Date: Saturday, November 4, 2023 Time: 10:00
a.m. – 12:00 p.m. ET Location: Poster Hall, #SA-PO010
ACR 2023 Oral and Poster
Presentations:
Title: Comparison of
Dual-immunosuppressive Therapy with a Voclosporin-based,
Triple-immunosuppressive Regimen for Lupus Nephritis in the ALMS
and AURORA 1 Studies Authors: Maria Dall’Era, Ernie
Yap, Matt Truman, Lucy Hodge, Neil Solomons Date: Sunday,
November 12, 2023 Time: 2:00 p.m. – 3:30 p.m. PT Oral
Session: Abstracts: SLE-Treatment I: Renal
Title: Selective Disposition of
Voclosporin, Cyclosporine, and Tacrolimus in Renal Tissue
Authors: Simon Zhou, Krishani Kumari Rajanayake, Miao
He, Bo Wen, Ankhbayar Lkhagva, Ernie Yap, Duxin Sun, Jennifer
Cross, Kory Engelke, Robert B. Huizinga Date: Sunday,
November 12, 2023 Time: 9:00 a.m. – 11:00 a.m. PT
Session: SLE-Treatment Poster I
Title: Long-term Safety and
Efficacy of Voclosporin in Black Patients with Lupus Nephritis:
Results from the AURORA 1 and AURORA 2 Studies
Authors: Gabriel Contreras, Matt Baker, Lucy Hodge, Ernie
Yap Date: Monday, November 13, 2023 Time: 9:00 a.m. –
11:00 a.m. PT Session: SLE-Treatment Poster II
Title: Efficacy and Safety of
Voclosporin in Patients with Proteinuria > 2 G/g
Authors: Emily Littlejohn, Salem Almaani, Vanessa
Birardi, Ernie Yap, Christopher Collins Date: Tuesday,
November 14, 2023 Time: 9:00 a.m. – 11:00 a.m. PT
Session: SLE-Treatment Poster III
Title: Paired Kidney Biopsies from
the AURORA 2 study of Voclosporin in Active Lupus Nephritis
Authors: Samir Parikh, Salem Almaani, Arnon Arazi, Huijuan
Song, Pearlly Yan, Estela Puchulu-Campanella, Clint Abner, Ernie
Yap, Krista Piper, Robert B. Huizinga, Henry Leher Date:
Tuesday, November 14, 2023 Time: 9:00 a.m. – 11:00 a.m. PT
Session: SLE-Treatment Poster III
About Lupus Nephritis Lupus Nephritis is a serious
manifestation of systemic lupus erythematosus (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, lupus nephritis can lead to permanent and
irreversible tissue damage within the kidney. Black and Asian
people with SLE are four times more likely to develop lupus
nephritis and Hispanic people are approximately twice as likely to
develop the disease, compared to White people with SLE. Black and
Hispanic people with SLE also tend to develop lupus nephritis
earlier and have worse outcomes, compared to White people with
SLE.
About LUPKYNIS® LUPKYNIS® is the first U.S. Food and Drug
Administration and European Commission-approved oral medicine for
the treatment of adult patients with active 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 with high unmet
medical needs that are impacted by autoimmune, kidney and rare
diseases. 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), 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.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20231013432160/en/
Media Inquiries: Andrea Christopher, Corporate
Communications Director, Aurinia achristopher@auriniapharma.com
Investor Inquiries: ir@auriniapharma.com
Aurinia Pharmaceuticals (NASDAQ:AUPH)
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