Data to highlight the safety, tolerability and
efficacy of LUPKYNIS in patients with lupus nephritis
Aurinia Pharmaceuticals Inc. (NASDAQ: AUPH) (Aurinia or the
Company), a biopharma company committed to delivering therapeutics
that change the course of autoimmune disease, today announced that
data from multiple studies of LUPKYNIS™ (voclosporin) for the
treatment of people with lupus nephritis (LN), a serious
complication of systemic lupus erythematosus (SLE) resulting in
potentially life-threatening damage to the kidneys, will be
presented at American Society of Nephrology (ASN) Kidney Week 2021
and at American College of Rheumatology (ACR) Convergence 2021. ASN
Kidney Week will take place virtually on November 2-7 and ACR
Convergence will take place virtually on November 3-9.
“Aurinia is committed to growing the body of clinical research
supporting LUPKYNIS as a safe and effective option for people with
lupus who are fighting to protect their kidneys from the
destructive impact of lupus nephritis,” said Neil Solomons, M.D.,
Chief Medical Officer at Aurinia. “We look forward to presenting
new data for LUPKYNIS at ASN and ACR, including an updated interim
analysis of data from the AURORA 2 continuation study evaluating
the long-term safety and tolerability of LUPKYNIS.”
The accepted abstract presentations and posters are listed below
and can be viewed virtually from November 4-6 at ASN and from
November 8-9 at ACR. The details are listed as follows.
Virtual ASN Kidney Week 2021
Presentations and Posters:
Thursday, November 4, 2021
Title: “Chronic Dosing of Voclosporin
at Clinically Relevant Exposure Levels Does Not Induce Renal
Fibrosis Markers in Rats” Presenting author: Linda M.
Rehaume, Ph.D., senior research scientist at Aurinia Time:
Available on-demand beginning at 10:00 a.m. PDT
Saturday, November 6, 2021
Title: “Voclosporin is Effective in
Achieving Complete Renal Response in Severe Lupus Nephritis”
Presenting author: Hanni Menn-Josephy, M.D., Boston Medical
Center Time: 4:30 p.m. - 5:30 p.m. PDT
Virtual ACR Convergence 2021
Presentations and Posters:
Monday, November 8, 2021
Title: “Voclosporin for Lupus
Nephritis: Interim Analysis of the AURORA 2 Extension Study”
Presenting author: Amit Saxena, M.D., NYU School of Medicine
Session: Plenary III (1424–1429) Time: 10:45 a.m. -
11:00 a.m. EST
Tuesday, November 9, 2021
Title: “ Voclosporin is Effective in
Achieving Complete Renal Response Across Lupus Nephritis Biopsy
Classes: Pooled Data from the AURA-LV and AURORA 1 Trials”
Presenting author: Anca Askanase, M.D., M.P.H., Columbia
University Medical Center Session: SLE – Treatment Poster
(1732–1772) Time: 8:30 a.m. - 10:30 a.m. EST
Title: “Efficacy of Voclosporin in
Recent Onset Lupus Nephritis” Presenting author: Meggan
Mackay, M.D., M.S., Feinstein Institute for Medical Research
Session: SLE – Treatment Poster (1732–1772) Time:
8:30 a.m. - 10:30 a.m. EST
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
LUPKYNIS™ is the first FDA-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
Aurinia 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.
The Company recently introduced the first FDA-approved oral therapy
indicated for the treatment of adult patients with active lupus
nephritis (LN). Aurinia’s head office is in Victoria, British
Columbia; its U.S. commercial hub is in Rockville, Maryland; and
the Company focuses development efforts globally.
INDICATION AND IMPORTANT SAFETY INFORMATION
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
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.
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
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
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.
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
Pregnancy/Lactation: May cause fetal harm. Advise not to
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.
version on businesswire.com: https://www.businesswire.com/news/home/20211026005821/en/
Media: Dana Lynch Corporate Communications, Aurinia
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