Voclosporin

RSS Otsuka Pharmaceutical Co., Ltd. (Otsuka) announces that Lupkynis® (voclosporin) has been launched today for the treatment of lupus nephritis (LN), an inflammation of the kidneys caused by systemic lupus erythematosus, an autoimmune disease. Lupkynis is a novel, oral immunosuppressive agent developed for the treatment of LN. It suppresses the immune system by inhibiting calcineurin, an enzyme that is crucial for the proliferation and activation of T cells, an important element of the immune system. In December 2020, Otsuka and Aurinia Pharmaceuticals Inc. entered into a collaboration and license agreement for the development and commercialization of oral voclosporin for the treatment of LN in Japan and European countries. In September 2022 Otsuka received European Commission approval for Lupkynis as a treatment for active LN in EU member countries. Otsuka subsequently received approval for Lupkynis in Japan in Septermber this year. In the U.S., Aurinia received FDA marketing approval in January 2021 for Lupkynis as a treatment for active LN in adults. Otsuka Pharmaceutical is committed to research and development that contributes to patients and their families in order to meet unmet medical needs worldwide. Our research priorities, in addition to autoimmune diseases, include mental, renal and cardiovascular health, and the often-ignored disease tuberculosis.

ROCKVILLE, Md. & EDMONTON, Alberta--( BUSINESS WIRE )--Aurinia Pharmaceuticals Inc. (NASDAQ: AUPH) (Aurinia or the Company), announced today the acceptance of four poster presentations at the annual American College of Rheumatology Convergence (ACR) 2024 taking place in Washington, D.C., November 14-19. The data highlight the need for additional screening for lupus nephritis (LN), a serious manifestation of systemic lupus erythematosus (SLE), and reinforce the clinical importance of LUPKYNIS ® (voclosporin), a second generation calcineurin inhibitor (CNI), for the treatment of adults with active LN. “ The data we are presenting at ACR highlight the pivotal role the rheumatology community must play in diagnosing and managing lupus nephritis. Rheumatologists are on the frontlines of ensuring early detection through routine screenings and of managing LN appropriately with LUPKYNIS, which is backed by robust clinical and real-world evidence,” said Dr. Greg Keenan, Chief Medical Officer of Aurinia. New real-world demographic data highlight high prevalence of LN among people with SLE Using the American Rheumatology Network (ARN) electronic medical records database to understand potential renal involvement and possible signs of LN, the study included 8,631 SLE patients receiving care from community rheumatologists over a five-year time period. The analysis found that 62% of these SLE patients had ICD-10 coding or clinical laboratory measurements suggestive of LN. Of the patients with suspected LN, 97% had an eGFR assessment, compared to 66% and 62% of patients who had a protein assessment by urine test strip or urine protein, respectively. Additionally, 40% of the patients with suspected LN had an ICD-10 code specifically for LN, compared to 60% with ICD-10 codes indicating kidney conditions, eGFR decrease, or proteinuria. “ The overwhelming majority of people living with SLE show signs of potential kidney involvement. However, our analysis suggests that many SLE patients are not receiving proper kidney screenings, and that LN is under-recognized and under-coded. A more proactive approach, including regular screening for proteinuria, is crucial for earlier detection and treatment of LN to minimize irreversible kidney damage,” said Dr. Nehad Soloman, lead study author and board-certified rheumatologist. Rates of Sustained, Complete Renal Response with Long-Term Use of LUPKYNIS in LN An analysis from the Phase 3 AURORA 1 and 2 studies highlighted the long-term efficacy of LUPKYNIS in people with LN. This study focused on a new efficacy endpoint, sustained complete renal response (SCRR), defined by the United States Food and Drug Administration (FDA) as achieving a complete renal response (CRR) at 12 months in AURORA 1 and at all study visits in the 2-year AURORA 2 continuation study. Significantly more LUPKYNIS patients achieved SCRR compared to patients receiving placebo. The SCRR endpoint was included in an FDA-approved label update for LUPKYNIS earlier this year. Additional studies to be presented at ACR assessed the effectiveness of tools aimed at measuring patient-reported outcomes using data from the AURORA clinical program. Following is the complete guide to Aurinia’s accepted abstracts at ACR 2024: Title: Validity, Reliability and Responsiveness of Lupus Impact Tracker and LupusPRO: AURORA Trial Authors: Meenakshi Jolly, Matt Truman, Ronald Flauto, Kathryn Dao Date: Saturday, November 16, 2024 Time: 10:30 a.m. – 12:30 p.m. ET Abstract Number: 0661 Title: Rates of Sustained Complete Renal Response with Long-term Use of Voclosporin in AURORA 2 Authors: Ernie Yap, Matt Truman, Cynthia Auguste, Vanessa Birardi, Greg Keenan Date: Sunday, November 17, 2024 Time: 10:30 a.m. – 12:30 p.m. ET Abstract Number: 1545 Title: Patient Reported Outcomes Analyses from AURORA 1 Clinical Trial: Lupus Impact Tracker and LupusPRO Authors: Meenakshi Jolly, Matt Truman, Ronald Flauto, Kathryn Dao Date: Sunday, November 17, 2024 Time: 10:30 a.m. – 12:30 p.m. ET Abstract Number: 1538 Title: Characterizing the Population with Suspected Lupus Nephritis in Care of a Community Rheumatology Network Authors: Nehad Soloman, Jawad Bilal, Romy Cabacungan, Scott Milligan, Andrew Sharobeem, John Tesser, Henry Leher Date: Monday, November 18, 2024 Time: 10:30 a.m. – 12:30 p.m. ET Abstract Number: 2415 About Lupus Nephritis Lupus nephritis (LN) is a serious manifestation of systemic lupus erythematosus (SLE), a chronic and complex autoimmune disease. LN affects approximately 120,000 people in the U.S. and disproportionately affects women and people of color. People living with LN have high unmet needs and often face significant barriers to optimal care. If poorly controlled, LN can lead to permanent and irreversible tissue damage within the kidney. Medical guidelines recommend that all SLE patients receive routine LN screenings at every visit. Guidelines also note that delaying LN diagnosis has profound prognostic repercussions. Yet, research shows that approximately 50% of SLE patients are not screened for LN and 77% of people with LN go untreated. Aurinia is committed to improving health outcomes for people living with LN by educating patients and providers on the critical need for routine screening and transformative therapies that can help improve health outcomes. About LUPKYNIS LUPKYNIS is a second generation 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 AURORA Clinical Program, comprised of the AURORA 1 pivotal trial and AURORA 2 extension trial, demonstrated the importance of LUPKYNIS plus standard of care to preserve kidney health in patients with active LN without reliance on chronic high-dose glucocorticoids. It is the only clinical program to include three years of LN treatment and follow-up with mycophenolate mofetil (MMF) and steroids. About Aurinia Aurinia Pharmaceuticals is a fully integrated biopharmaceutical company focused on delivering therapies to people living with autoimmune diseases with high unmet medical needs. 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. Aurinia is also developing AUR200, a differentiated, potential best-in-class therapy for autoimmune diseases that targets both BAFF (B-cell Activating Factor) and APRIL (A Proliferation-Inducing Ligand). 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 lupus nephritis (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 lead to serious, including fatal outcomes. Nephrotoxicity: LUPKYNIS, like other calcineurin inhibitors (CNIs), may cause acute and/or chronic nephrotoxicity. The risk is increased when CNIs are concomitantly administered with drugs associated with nephrotoxicity. Monitor eGFR regularly. Hypertension: Hypertension is a common adverse reaction of LUPKYNIS therapy and may require antihypertensive therapy. Monitor blood pressure regularly. 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. Monitor for neurologic symptoms. 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. Monitor serum potassium levels periodically. 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. Co-administration of LUPKYNIS with strong CYP3A4 inhibitors is contraindicated. Reduce LUPKYNIS dosage when co-administered with moderate CYP3A4 inhibitors. Avoid use of LUPKYNIS with strong or moderate CYP3A4 inducers. 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: Avoid use of LUPKYNIS. Lactation: Consider the mother’s clinical need for LUPKYNIS and any potential adverse effects to the breastfed infant when prescribing LUPKYNIS to a lactating woman. Renal Impairment: LUPKYNIS is not recommended in patients with baseline eGFR ≤45 mL/min/1.73 m 2 unless benefit exceeds risk. If used in this population, reduce LUPKYNIS dose. Hepatic Impairment: For mild or moderate hepatic impairment, reduce LUPKYNIS dose. Avoid use with severe hepatic impairment. Please see Prescribing Information , including Boxed Warning, and Medication Guide for LUPKYNIS.