Presentations include new analyses of AURORA 1
and details on the ENLIGHT-LN registry
Aurinia Pharmaceuticals Inc. (NASDAQ: AUPH) (Aurinia or the
Company), a biopharmaceutical company committed to delivering
therapeutics that change the course of autoimmune disease, today
announced that data from multiple studies of LUPKYNIS™
(voclosporin) will be presented at the 2022 National Kidney
Foundation Spring Clinical Meetings, taking place April 6-10, 2022
in Boston, Mass.
“Aurinia is committed to expanding the body of research
supporting the clinical benefits of LUPKYNIS, the first
FDA-approved oral therapy available to people living with lupus
nephritis,” said Neil Solomons, M.D., Chief Medical Officer at
Aurinia. “We look forward to sharing updates at the National Kidney
Foundation’s Spring Clinical Meetings, including the design of a
prospective observational registry of patients treated with
LUPKYNIS.”
Abstracts are available online at:
https://casehippo.com/spa/courses/resource/2022-spring-clinical-meetings/event/home/posters/browser
Presentations related to LUPKYNIS at
the meetings include:
Title: “The Efficacy of Voclosporin in Lupus Nephritis is
Independent of Changes in Anti-dsDNA and Complement at Week 52”
Poster number: 314 Presenting author: Betty Diamond,
M.D., Director of the Institute of Molecular Medicine & Maureen
and Ralph Nappi Professor of Autoimmune Diseases, Feinstein
Institutes for Medical Research, Manhasset, New York
Title: “ENLIGHT-LN: A Prospective Observational Registry
of Patients Treated with Voclosporin for Lupus Nephritis in the
United States” Poster number: 318 Presenting author:
Keely Dahl, PharmD, Associate Medical Director, Aurinia
Pharmaceuticals Inc.
Title: “Attainment of Complete Renal Response Results in
Significant Improvements in Lupus Impact Tracker in the AURORA 1
Study of Voclosporin in Lupus Nephritis” Poster number: 319
Presenting author: Meenakshi Jolly, M.D., M.S., Associate
Professor, Rush University, Chicago
Title: “Confirmation of the Immunosuppressive Function of
Voclosporin at the Clinically Relevant Lupus Nephritis Dose in
Lupus-prone Mice” Poster number: 327 Presenting
author: Linda M. Rehaume, Ph.D., Senior Research Scientist,
Aurinia Pharmaceuticals Inc.
About Lupus Nephritis Lupus nephritis (LN) 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 approximately one out of three of these
individuals develop LN. If poorly controlled, LN can lead to
permanent and irreversible tissue damage within the kidney,
resulting in kidney failure. 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 FDA-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 that are impacted
by serious diseases with a high unmet medical need. In January
2021, the Company introduced LUPKYNIS™ (voclosporin), the first
FDA-approved oral therapy for the treatment of adult patients with
active LN. The Company’s head office is in Victoria, British
Columbia, its U.S. commercial hub is in Rockville, Maryland, and
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/20220404005904/en/
Media: Dana Lynch Corporate Communications, Aurinia
dlynch@auriniapharma.com
Investors: aurinia@westwicke.com
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