Aurinia Pharmaceuticals Inc. (NASDAQ: AUPH) (Aurinia or the
Company) today announced that the Japanese Ministry of Health,
Labour, and Welfare has approved voclosporin, a second-generation
calcineurin inhibitor, in combination with mycophenolate mofetil
(MMF) to treat lupus nephritis (LN).
The Company’s collaboration partner, Otsuka Pharmaceutical Co.,
Ltd., filed the new drug application (NDA) with Japanese regulatory
authorities in November 2023. The approval is based on data from
the AURORA Clinical Program, which included a 12-month, Phase 3,
double-blind, randomized-controlled study, as well as a two-year
extension study, assessing the efficacy and safety of voclosporin
with MMF and low-dose glucocorticoids, compared to MMF and low-dose
glucocorticoids alone, in LN patients.
“We are thrilled to achieve this milestone that will provide
access to LUPKYNIS in Japan, where there is a high rate of lupus
nephritis among Japanese lupus patients. Our successful strategic
partnership with Otsuka has allowed us to bring LUPKYNIS to LN
patients across Europe and now Japan, addressing a significant
unmet need,” said Peter Greenleaf, President, and Chief Executive
Officer of Aurinia.
Aurinia and Otsuka entered a collaboration and licensing
agreement in December 2020 for the development and
commercialization of oral voclosporin in the EU, Japan, the United
Kingdom, Russia, Switzerland, Norway, Belarus, Iceland,
Liechtenstein, and Ukraine. As part of the agreement, Aurinia is
eligible to receive a payment of $10 million U.S. dollars upon
approval in Japan along with low double-digit royalties on net
sales once launched. The Company will supply product to Otsuka to
support the launch under the associated commercial supply agreement
on a cost-plus basis.
In January 2021, the U.S. Food and Drug Administration (FDA)
approved voclosporin in combination with a background
immunosuppressive therapy regimen for the treatment of adult
patients with active LN and it is currently available in the U.S.
under the brand name LUPKYNIS.
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 m2 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.
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version on businesswire.com: https://www.businesswire.com/news/home/20240924775622/en/
Media & Investor Inquiries: Andrea Christopher
Corporate Communications & Investor Relations Aurinia
Pharmaceuticals Inc. achristopher@auriniapharma.com General
Investor Inquiries: ir@auriniapharma.com
Aurinia Pharmaceuticals (NASDAQ:AUPH)
過去 株価チャート
から 10 2024 まで 11 2024
Aurinia Pharmaceuticals (NASDAQ:AUPH)
過去 株価チャート
から 11 2023 まで 11 2024
