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 59th European
Renal Association (ERA) Congress and at the European Congress of
Rheumatology, European Alliance of Associations for Rheumatology
(EULAR) 2022. The 2022 ERA Congress will take place virtually and
in Paris on May 19-22 and the EULAR 2022 Congress will take place
virtually and in Denmark on June 1-4.
“Aurinia continues to expand its clinical evidence supporting
LUPKYNIS as a reliable treatment option for people and HCPs working
to protect their patients’ kidneys from the devastating impact of
lupus nephritis,” said Neil Solomons, M.D., Chief Medical Officer
at Aurinia. “We look forward to presenting new data for LUPKYNIS at
the ERA and EULAR Congresses, including our results from the
two-year AURORA 2 continuation study evaluating the long-term
safety and tolerability of LUPKYNIS for the treatment of lupus
nephritis.”
Scientific programs and information for the ERA Congress and
EULAR Congress are available online at
https://www.era-online.org/en/paris2022/ and
https://congress.eular.org/index.cfm respectively. The presentation
details are as follows.
ERA Congress 2022
Presentations:
Title: “Voclosporin for Lupus
Nephritis: Results of the Two-year AURORA 2 Continuation Study”
Presenting author: Y.K. Onno Teng, M.D., Ph.D., President of
the National Foundation of the Autoimmune Research &
Collaboration Hubs (ARCH) Date: Friday, May 20, 2022
Time: 17:00-18:30 CEST
Title: “Early Reductions in
Proteinuria with Voclosporin Treatment 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 Date: Friday, May 20, 2022
Time: 17:43-17:58 CEST
EULAR Congress 2022 Presentations and
Posters:
Title: “Voclosporin for Lupus
Nephritis: Results of the Two-year AURORA 2 Continuation Study”
Presenting author: Amit Saxena, M.D., NYU School of Medicine
Date: Friday, June 3, 2022 Time: 12:26-12:34 CEST
Title: “Voclosporin is Effective in
Achieving Proteinuria Treatment Targets in Lupus Nephritis Defined
by EULAR/ERA Recommendations” Presenting author:
Hans-Joachim Anders, Professor of Nephrology and Head of Renal
Division, University of Munich (LMU) Date: Friday, June 3,
2022 Time: 10:30-12:00 CEST
LUPKYNIS is the first U.S. FDA-approved oral medicine for the
treatment of adult patients with active lupus nephritis (LN). In
June 2021, Aurinia, with its licensing partner, Otsuka
Pharmaceutical Europe Ltd. (OPEL), filed an initial Marketing
Authorization Application (MAA) for voclosporin for the treatment
of lupus nephritis (LN) to the European Medicines Agency (EMA).
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 will 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 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 oral therapy for the
treatment of adult patients with active lupus nephritis (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.
Investor and Media: 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/20220516005390/en/
Media: Dana Lynch Corporate Communications, Aurinia
dlynch@auriniapharma.com
Investors: aurinia@westwicke.com
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