MHRA Approval follows European Commission
marketing authorization of LUPKYNIS to treat adults with active
lupus nephritis in 27 European Union Member States
LUPKYNIS is the first oral medicine approved in
the U.S. and Europe for the treatment of adults living with active
Aurinia Pharmaceuticals Inc. (NASDAQ:AUPH)
(Aurinia or the Company), a biopharmaceutical company committed to
delivering therapeutics that change the trajectory of autoimmune
disease, announced that the U.K. Medicines and Healthcare products
Regulatory Agency (MHRA) has granted the Great Britain marketing
authorization of LUPKYNIS® (voclosporin) to treat adults with
active lupus nephritis (LN), a serious complication of systemic
lupus erythematosus (SLE).
“The MHRA authorization of LUPKYNIS for individuals with lupus
nephritis in Great Britain, on the heels of the marketing
authorization in the EU, further expands the availability of
LUPKYNIS as a treatment option for people with lupus nephritis,”
said Peter Greenleaf, President and Chief Executive Officer,
Aurinia. “Otsuka has been a valued partner in these efforts, and we
are pleased to work with them to reach new patients.”
The marketing authorization by the MHRA, which follows the
European Commission (EC) authorization on September 19, 2022, is
based on the Phase 3 AURORA 1 study and the AURORA 2 continuation
study, which demonstrated voclosporin, in combination with
mycophenolate mofetil (MMF) and low-dose corticosteroids, led to
statistically superior complete renal response rates at 52 weeks
compared to MMF and low-dose corticosteroids alone. The safety
profile of voclosporin and MMF and low-dose corticosteroids was
generally comparable to MMF and low-dose corticosteroids alone.
In addition, a marketing authorization application for LUPKYNIS
was submitted to the Swiss Agency for Therapeutic Products
(Swissmedic) and is currently under review. Swissmedic previously
granted orphan drug status to voclosporin in LN in February
Aurinia and Otsuka Pharmaceutical Co., Ltd., (Otsuka) entered a
collaboration and licensing agreement in December 2020 for the
development and commercialization of voclosporin for the treatment
of LN in the United Kingdom, EU, Japan, Russia, Switzerland,
Norway, Belarus, Iceland, Liechtenstein, and Ukraine.
About Lupus Nephritis
LN is a serious manifestation of SLE, a chronic and complex
autoimmune disease. About 200,000-300,000 people live with SLE in
the U.S. and about one-third of these people are diagnosed with
lupus nephritis at the time of their SLE diagnosis. About 50
percent of all people with SLE may develop lupus nephritis. If
poorly controlled, LN can lead to permanent and irreversible tissue
damage within the kidney. 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.
LUPKYNIS® is the first U.S. FDA- and EC-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
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 dedicated for
the treatment of adult patients with active lupus nephritis. The
Company’s head office is in Victoria, British Columbia, its U.S.
commercial office is in Rockville, Maryland. The Company focuses
its 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
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.
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