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) will be presented at the American Society of Nephrology (ASN) Kidney Week 2022, taking place November 3-6 in Orlando, Florida. These presentations by several leading experts in nephrology build on the robust evidence supporting 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 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., Boston University School of Medicine, Boston, Massachusetts
Date: Friday, November 4, 2022
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 the United States
Presenting author: Keith J. Tagoe, Pharm.D., R.Ph., Aurinia Pharmaceuticals Inc, Rockville, Maryland
Date: Thursday, November 3; Friday, November 4; Saturday, November 5, 2022
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: Dawn Caster, M.D., University of Louisville, Louisville, Kentucky
Date: Friday, November 4, 2022
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: Samir V. Parikh, M.D., The Ohio State University Wexner Medical Center, Columbus, Ohio
Date: Thursday, November 3, 2022
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: Ramesh Saxena, M.D., Ph.D., The University of Texas Southwestern Medical Center, Dallas, Texas
Date: Thursday, November 3, 2022
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, Ann Arbor, Michigan
Date: Saturday, November 5, 2022
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 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 and EC-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.
View source version on businesswire.com: https://www.businesswire.com/news/home/20221027005381/en/
Contacts
Investor Relations
Aurinia@westwicke.com
