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EDMONTON, Alberta--(BUSINESS WIRE)-- Aurinia Pharmaceuticals Inc. (NASDAQ: AUPH) (Aurinia or the Company) today announced that full results from the Phase 3, double-blind, placebo-controlled AURORA 2 extension study were published online in Arthritis & Rheumatology, the official peer-reviewed journal of the American College of Rheumatology. As part of the AURORA Clinical Program, the AURORA 2 extension study assessed the long-term safety and tolerability of LUPKYNIS® (voclosporin), compared with placebo, in combination with mycophenolate mofetil and low-dose glucocorticoids, to treat active lupus nephritis (LN) in adult patients who completed one year of treatment in the Phase 3 AURORA 1 clinical trial. Voclosporin was well tolerated with no new or worsening safety signals in the extension study. Clinical efficacy over three years of treatment was maintained, as observed by maintenance of urine protein creatinine ratio (UPCR) reductions, sustained complete renal response (CRR) and preserved kidney function, suggesting a positive benefit-risk pro voclosporin in LN patients. “Proteinuria, a defining part of the characterization of chronic kidney disease, often precedes a decline in kidney function and is associated with progression to kidney failure. Reductions in proteinuria are critical for slowing or stopping progression to end-stage kidney disease and improving long-term outcomes for LN patients. Notably, in this extension study, kidney preservation, sustained renal response, and reductions in steroid use were achieved with voclosporin. These findings demonstrate the critical importance of voclosporin in the management of LN to improve patient outcomes,” said lead study author Amit Saxena, MD, Division of Rheumatology, New York University Grossman School of Medicine. Estimated glomerular filtration rate (eGFR), an important measurement of kidney function, remained stable throughout the extension study. The slope of the change in eGFR over the extension study period at month 36 demonstrated kidney function preservation in the voclosporin group (-0.2 mL/min/1.73m2), compared with a decline in function after one year in the control group (-5.4 mL/min/1.73m2). There was a significant increase in achievement of CRR in LN patients treated with voclosporin, compared to patients in the control group, at nearly every time point in the AURORA Clinical Program. At month 12, CRR occurred in 52.6% of patients who received voclosporin, compared to 34.0% in the control group, largely driven by achieving a proteinuria reduction in UPCR to ≤0.5 mg/mg. At month 36, CRR occurred in 50.9% of patients who received voclosporin, compared to 39.0% of patients in the control group. CRR was defined as UPCR of ≤0.5 mg/mg, eGFR ≥60 ml/min/1.73 m2 or no confirmed decrease from pretreatment baseline in eGFR of >20%, no rescue medication received for LN, and not receiving more than 10 mg of glucocorticoids for ≥3 consecutive days or for ≥7 days in total during the eight weeks prior to renal response assessment. These results were achieved with most patients in both groups (>75%) maintaining glucocorticoid tapering throughout the study and receiving doses of ≤2.5 mg/day at the end of the extension study. Of those who experienced adverse events (AEs) in the extension study, most were mild or moderate (86% in the voclosporin group vs. 81% in the control group). Across three years of treatment, infections were the most common type of AE (69.8% in the voclosporin group vs. 72.0% in the control group), with low rates of serious infections in both groups (12.9% in the voclosporin group vs. 17.0% in the control group). Most adverse events declined annually over the study period, with 86.1% of patients completing the two-year extension. “The results of this extension study reinforce the long-term safety and effectiveness of LUPKYNIS to stabilize kidney function in those diagnosed with LN, a debilitating, yet common complication that occurs in about half of people with lupus,” said Dr. Greg Keenan, Chief Medical Officer of Aurinia. “Together, AURA-LV, AURORA 1, and AURORA 2 represent one of the largest and longest placebo-controlled clinical programs evaluating the treatment of LN. We are proud of our sustained research in autoimmune diseases like lupus and remain committed to helping improve kidney health for people living with lupus nephritis.” About the AURORA Clinical Program In AURORA 1 (NCT03021499), a 12-month, phase 3, double-blind, randomized-controlled pivotal study, the efficacy and safety of voclosporin was compared with a control group in achieving CRR in patients with LN. AURORA 1 demonstrated the clinical superiority of voclosporin with mycophenolate mofetil (MMF) and low-dose glucocorticoids compared to MMF and low-dose glucocorticoids alone. Significantly more patients in the voclosporin group achieved a CRR at 52 weeks of treatment and did so significantly faster than those in the control group. The safety pro AURORA 1 was comparable between treatment groups, in line with previous studies; no new safety concerns were observed. Results from the completed Phase 3 randomized, double-blind, placebo-controlled, multicenter AURORA 1 study were published in The Lancet. AURORA 2 (NCT03597464) is a Phase 3, double-blind, extension study to assess the long-term safety and tolerability of voclosporin, in addition to MMF and low-dose glucocorticoids, for the treatment of patients with active LN. Patients who completed 12 months of treatment in the Phase 3 AURORA 1 study were eligible to enroll in the AURORA 2 extension study with the same randomized treatment of voclosporin or placebo, in combination with MMF (target dose of 2 g/day) and low-dose glucocorticoids (target dose of ≤2.5 mg/day), for an additional 24 months. A total of 216 LN patients continued into the extension study, with 116 patients in the voclosporin group and 100 patients in the control group; 90 and 78 patients, respectively, received 36 months of total treatment at the completion of the study. Study drug dose changes decreased over time. 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 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. References: Saxena A., Ginzler E., Gibson K., Satirapoj B., Santillán A., Levchenko O., Navarra S., Atsumi T., Yasuda S., Chavez-Perez N., Arriens C., Parikh S., Caster D., Birardi V., Randhawa S., Lisk L., Huizinga R., Teng O. (2023), Safety and Efficacy of Long-Term Voclosporin Treatment for Lupus Nephritis in The Phase 3 AURORA 2 Clinical Trial. Arthritis Rheumatol. Accepted Author Manuscript:

As potential therapies are being investigated to manage idiopathic membranous nephropathy, it is safe to predict that the idiopathic membranous nephropathy market will experience significant reconstitution during 2023–2032. However, the challenges of the rigid and burdensome structure of regulatory authorities will decide the fate of all these pipeline therapies and the impact they will have on overall revenue generation. LAS VEGAS, June 1, 2023 /PRNewswire/ -- DelveInsight's Idiopathic Membranous Nephropathy Market Insights report includes a comprehensive understanding of current treatment practices, idiopathic membranous nephropathy emerging drugs, market share of individual therapies, and current and forecasted market size from 2019 to 2032, segmented into 7MM [the United States, the EU-4 (Italy, Spain, France, and Germany), the United Kingdom, and Japan] and China. Key Takeaways from the Idiopathic Membranous Nephropathy Market Report As per DelveInsight analysis, the idiopathic membranous nephropathy market size in the 7MM + China was approximately USD 220 million in 2022. According to the assessment done by DelveInsight, the estimated total prevalent idiopathic membranous nephropathy cases in the 7MM + China were approximately 380K in 2022. Leading idiopathic membranous nephropathy companies such as Hoffmann-La Roche, MorphoSys, Cerium Pharmaceuticals, BeiGene, Reistone Biopharma, Eternity Bioscience, GlaxoSmithKline, ValenzaBio, ACELYRIN, and others are developing novel Idiopathic Membranous Nephropathy drugs that can be available in the Idiopathic Membranous Nephropathy market in the coming years. The promising idiopathic membranous nephropathy therapies in the pipeline include GAZYVA (obinutuzumab), MOR202 (felzartamab), SNP-ACTH (1-39) Gel, BRUKINSA (zanubrutinib), SHR1459 (edralbrutinib), BENLYSTA (belimumab), VB119 , and others. Discover which therapies are expected to grab the major idiopathic membranous nephropathy market share @ Idiopathic Membranous Nephropathy Market Report Idiopathic Membranous Nephropathy Overview Membranous nephropathy is a kidney disease affecting the kidney's filters. It causes a rise in protein in the urine, impaired renal function, and edoema. It's also known as membranous glomerulopathy. Membranous nephropathy is a rare disease that affects the renal glomerulus, specifically the podocytes, which play an important role in limiting the permeability of the kidney to proteins. The most common membranous nephropathy symptom is swelling, often known as edema. This might range from minor to severe. Most patients have some edema, which is generally the initial symptom. Swelling in membranous nephropathy is usually slow compared to other disorders that cause protein in the urine and nephrotic syndrome, but it can sometimes be sudden. It usually begins in the feet, ankles, or legs, although it can develop elsewhere in the body, including the abdomen, hands, arms, and face. Protein in the urine is frequently used to make membranous nephropathy diagnosis. A blood test, a kidney biopsy, optical microscopy, immunofluorescence, electron microscopy, and antibody-guided diagnostics are also conducted. Idiopathic Membranous Nephropathy Epidemiology Segmentation DelveInsight estimates that there were approximately 380K prevalent cases of idiopathic membranous nephropathy in the 7MM in 2022. China contributed to the largest prevalent population of idiopathic membranous nephropathy, acquiring ~82% of the 7MM and China in 2022. Whereas EU4 and the UK for ~6%, and Japan accounted for ~ 5% of the total population share, in 2022. The idiopathic membranous nephropathy market report proffers epidemiological analysis for the study period 2019–2032 in the 7MM + China segmented into: Idiopathic Membranous Nephropathy Prevalence Idiopathic Membranous Nephropathy Prevalence by Antigens Idiopathic Membranous Nephropathy Treatment Market There is no cure for either primary or secondary membranous nephropathy. When treating individuals with the illness, doctors usually take a symptomatic approach and aim to improve the patient's immune system. Patients are put on supportive care as soon as the diagnosis is confirmed, regardless of the underlying cause, and this is continued throughout the duration of the condition. It includes careful blood pressure control, angiotensin-converting enzyme inhibitor/angiotensin receptor blocker therapy to reduce proteinuria and increase the chances of spontaneous remission, statins for hyperlipidemia, salt restriction, diuretics to control edoema, and a low protein diet to allow for the replacement of urinary protein losses. In recent research, alkylating drugs used in combination with corticosteroids produced positive results in membranous nephropathy patients. Immunosuppressive therapy (such as steroids and alkylating agents, calcineurin inhibitors (CNIs), and rituximab) are among the medications used to treat membranous nephropathy patients. Alkylating drugs, steroids, and calcineurin inhibitors (CNIs) have formed the foundation of immunosuppression and immunosuppressive medications. Though they are partially effective in reducing proteinuria in membranous nephropathy patients, they have also been linked to greater relapse rates and significant adverse responses. To know more about idiopathic membranous nephropathy treatment guidelines, visit @ Idiopathic Membranous Nephropathy Management Idiopathic Membranous Nephropathy Pipeline Therapies and Key Companies GAZYVA (obinutuzumab): Hoffmann-La Roche MOR202 (felzartamab): MorphoSys SNP-ACTH (1-39) Gel: Cerium Pharmaceuticals BRUKINSA (zanubrutinib): BeiGene SHR1459 (edralbrutinib): Reistone Biopharma/Eternity Bioscience BENLYSTA (belimumab): GlaxoSmithKline VB119: ValenzaBio/ACELYRIN Learn more about the FDA-approved drugs for idiopathic membranous nephropathy @ Drugs for Idiopathic Membranous Nephropathy Treatment Idiopathic Membranous Nephropathy Market Dynamics The dynamics of the idiopathic membranous nephropathy market are expected to change in the coming years. Increased research activities and the discovery of new biomarkers and therapeutic targets, will result in the development of improved medicines in the future. Although rituximab is effective, patients can acquire medication resistance over time. Roche's Obinutuzumab is being developed with improved efficacy, which will aid in overcoming the limits of current therapy. Moreover, the rapid incidence of progression and remission in membranous nephropathy patients provides pharmaceutical companies with an opportunity to develop therapies to address the inadequacies and capture a largely untapped idiopathic membranous nephropathy market. Only a few drugs, such as Obinutuzumab, are in the latter stages of development. As a result, it opens the door for additional pharmaceutical companies to enter the idiopathic membranous nephropathy market with fresh therapeutic choices. However, several factors may impede the growth of the idiopathic membranous nephropathy market. Due to knowledge gaps and a lack of clarity about membranous nephropathy pathology, there is an urgent scarcity of large-scale clinical studies assessing therapy alternatives in membranous nephropathy. The outcomes of idiopathic membranous nephropathy treatment candidates that are in various stages of clinical development and are expected to be launched are not available. As a result, establishing the safety and efficacy of these medications is difficult. Moreover, as membranous nephropathy is a rare indication, it is often overshadowed by more common and fatal renal diseases, thereby influencing the whole research and development process. Almost 30% of membranous nephropathy cases develop into ESRD, yet the therapeutic landscape is devoid of recognized medicines, leading to a high fatality rate. Scope of the Idiopathic Membranous Nephropathy Market Report Therapeutic Assessment: Idiopathic Membranous Nephropathy current marketed and emerging therapies Idiopathic Membranous Nephropathy Market Dynamics: Attribute Analysis of Emerging Idiopathic Membranous Nephropathy Drugs Competitive Intelligence Analysis: SWOT analysis and Market entry strategies Unmet Needs, KOL's views, Analyst's views, Idiopathic Membranous Nephropathy Market Access and Reimbursement Discover more about idiopathic membranous nephropathy drugs in development @ Idiopathic Membranous Nephropathy Clinical Trials Table of Contents Related Reports Idiopathic Membranous Nephropathy Epidemiology Forecast Idiopathic Membranous Nephropathy Epidemiology Forecast – 2032 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, and idiopathic membranous nephropathy epidemiology trends. Nephrotic Syndrome Pipeline Nephrotic Syndrome Pipeline Insight – 2023 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key nephrotic syndrome companies, including GlaxoSmithKline, Goldfinch Bio, Inc., Travere Therapeutics, Inc., Aurinia Pharmaceuticals, Bristol-Myers Squibb, ChemoCentryx, SynAct Pharma AB, among others. Nephrotic Syndrome Market Nephrotic Syndrome Market Insights, Epidemiology, and Market Forecast – 2032 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key nephrotic syndrome companies, including GlaxoSmithKline, Goldfinch Bio, Inc., Travere Therapeutics, Inc., Aurinia Pharmaceuticals, Bristol-Myers Squibb, ChemoCentryx, SynAct Pharma AB, among others. About DelveInsight DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports pharma companies by providing comprehensive end-to-end solutions to improve their performance. Get hassle-free access to all the healthcare and pharma market research reports through our subscription-based platform PharmDelve . Contact Us Shruti Thakur [email protected] +1(919)321-6187 Logo: SOURCE DelveInsight Business Research, LLP

EDMONTON, Alberta--(BUSINESS WIRE)-- Aurinia Pharmaceuticals Inc. (NASDAQ: AUPH) (Aurinia or the Company) today announced the results of a post-hoc, pooled analysis of the Phase 2 AURA-LV (NCT02141672) and Phase 3 AURORA 1 (NCT03021499) studies, which found that LUPKYNIS® with mycophenolate mofetil (MMF) and low-dose steroids resulted in earlier and greater reductions in proteinuria in lupus nephritis (LN) patients with high proteinuria across biopsy classes, races, and ethnicities. These data were presented at the European Congress of Rheumatology, EULAR 2023, in Milan, Italy. Consistent with results from the overall pooled study population, patients with urine protein creatinine ratio (UPCR) ≥2 g/g at baseline treated with LUPKYNIS® achieved significantly higher renal response rates than patients treated with MMF and low-dose steroids alone, regardless of baseline demographics or clinical characteristics. “Proteinuria is a common manifestation of LN that can lead to progressive kidney damage. Early reductions in UPCR have been shown to be predictive of improved long-term outcomes in LN. Yet, there remains the need for safe and effective therapies for patients with high proteinuria, especially given that monoclonal antibody therapies have demonstrated limited efficacy in LN patients with moderate to high proteinuria. These findings for voclosporin, a novel calcineurin inhibitor, are clinically relevant and can help improve renal outcomes for LN patients,” said lead study author Emily Littlejohn, D.O., M.P.H., Cleveland Clinic Main Campus, Rheumatologic and Immunologic Disease, Cleveland, Ohio. “We are pleased to present these findings that further support the efficacy and safety of a voclosporin-based treatment regimen across diverse LN patient populations. In this analysis, complete response rates favored voclosporin regardless of sex, race, ethnicity, baseline UPCR or baseline renal function. Patients who achieved complete renal response with voclosporin experienced stable renal function while undergoing a rapid steroid taper as part of the study. These findings further differentiate LUPKYNIS, a next-generation CNI, from legacy, first-generation CNIs,” said Dr. Greg Keenan, Chief Medical Officer of Aurinia. About the Analysis To further characterize the efficacy and safety of voclosporin in patients with high proteinuria, outcomes were analyzed in various subpopulations of patients with UPCR ≥2 g/g at baseline using the pooled dataset from the Phase 2 AURA-LV and Phase 3 AURORA 1 studies. Both studies enrolled patients with biopsy-proven LN (Class III, IV, or V ± III/IV) within 6 months (or up to 2 years in AURORA 1) and proteinuria ≥1.5 g/g (≥2 g/g for Class V). Patients were randomized to voclosporin (23.7 mg BID) or placebo and treated for up to one year (48 weeks in AURA-LV and 52 weeks in AURORA 1). All patients received MMF and low-dose steroids. Protocol-defined glucocorticoid taper included intravenous methylprednisolone on Days 1 and 2. Oral glucocorticoid was initiated on Day 3 with 20-25 mg/day prednisone and tapered to a target dose of 2.5 mg/day at Week 16 and thereafter. For the analysis, complete renal response (CRR) rates were evaluated in patients with baseline UPCR ≥2 g/g. CRR was defined as UPCR ≤0.5 g/g with stable renal function, low-dose steroids, and no rescue medication. Subgroup analyses were based on sex, age, race, ethnicity, biopsy class, and estimated glomerular filtration rate (eGFR) at baseline. Adverse events (AEs) and mean eGFR levels over time were also assessed. Of the 268 and 266 patients included in the voclosporin and control arms of the pooled analysis, respectively, 217 and 215 patients had a baseline UPCR ≥2 g/g (mean [SD], 5.1 [3.3] vs. 4.6 [2.8] g/g, respectively). At one year, the change from baseline in least squares mean UPCR was -3.8 (0.1) g/g in the voclosporin arm, compared to -3.1 (0.2) g/g in the control arm (difference vs. control, -0.7; p=0.0003). A significantly greater percentage of voclosporin-treated patients achieved CRR at one year compared to the control arm (41.0% vs. 21.9%; odds ratio [OR] 2.48). Across biopsy classes, the highest rates of CRR were observed in Class III patients treated with voclosporin (50% vs. 16.1% in control, p=0.0126), followed by Class IV (44% vs. 23.8%, p=0.0019), Class V with III or IV lesions (37.7% vs. 17% p=0.0306), and Class V (31.3% vs. 28.6%, p=0.81). CRR rates were numerically greater in subgroups of voclosporin-treated patients, including both sexes and across all ages, races, ethnicities, biopsy classes, and eGFR levels assessed, as indicated with OR>1. Similar rates of AEs were reported in both arms and mean eGFR levels were similar and stable over one year of treatment. 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. FDA- and EC-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 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. Reference Littlejohn E et al. Efficacy and Safety of Voclosporin across Patient Subgroups with Proteinuria ≥2 mg/mg: An Integrated Analysis of the AURA-LV and AURORA 1 Studies. Presented at EULAR 2023.