Aurinia Pharmaceuticals Announces Presentations at American Society of Nephrology (ASN) Kidney Week 2022
Aurinia Pharmaceuticals (NASDAQ:AUPH) announced that data from various studies of LUPKYNIS® (voclosporin) will be presented at the American Society of Nephrology (ASN) Kidney Week 2022 in Orlando, Florida, from November 3-6. The presentations will highlight LUPKYNIS's long-term safety and efficacy in treating active lupus nephritis (LN), a severe complication of systemic lupus erythematosus (SLE). Notable studies include efficacy over three years and a prospective registry of patients treated with voclosporin.
- Presentation of multiple studies on LUPKYNIS at ASN Kidney Week 2022, emphasizing long-term safety and efficacy.
- LUPKYNIS is the first FDA-approved oral treatment for active lupus nephritis.
- None.
The abstracts for ASN Kidney Week 2022 are listed below and available online at: https://www.asn-online.org/education/kidneyweek/2022/program-search-abstract.aspx
ASN Kidney Week 2022 Oral and Poster Presentations:
Title: Efficacy and Safety of Voclosporin Over Three Years in Patients with Severe Lupus Nephritis
Presenting author: Hanni Menn-Jospehy, M.D.,
Date:
Time: 5:33 p.m - 5:42 p.m ET
Session: FR-OR58
Title: Enlight-LN: A Prospective Observational Registry of Patients Treated with Voclosporin for Lupus Nephritis in
Presenting author:
Date:
Time: 10:00 a.m - 12:00 p.m ET
Session: INFO36
Title: Long-term Use of Voclosporin in Patients with Class V Lupus Nephritis: Results from the AURORA 2 Continuation Study
Presenting author:
Date:
Time: 10:00 a.m - 12:00 p.m ET
Session: FR-PO640
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:
Date:
Time: 10:00 a.m - 12:00 p.m ET
Session: TH-PO486
Title: Long-Term Safety and Efficacy Of Voclosporin in Patients With Lupus Nephritis and Low eGFR
Presenting author:
Date:
Time: 10:00 a.m - 12:00 p.m ET
Session: TH-PO488
Title: Voclosporin Therapy Induces Systemic Lipidomic Alterations: Implications for Lipid Mediators for Remission of Lupus Nephritis
Presenting author: Farsad Afshinnia, M.D., University of Michigan,
Date:
Time: 10:00 a.m - 12:00 p.m ET
Session: SA-PO688
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
About LUPKYNIS
LUPKYNIS® is the first
About Aurinia
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 (>
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/20221027005381/en/
Investor Relations
Aurinia@westwicke.com
Media
aurinia@healthandcommerce.com
Source:
FAQ
What studies on LUPKYNIS will be presented at ASN Kidney Week 2022?
When is the ASN Kidney Week 2022 event where LUPKYNIS studies will be presented?
What is the significance of LUPKYNIS for lupus nephritis treatment?