Aurinia Pharmaceuticals Inc. (NASDAQ: AUPH) (Aurinia or the
Company) today announced that the National Institute for Health and
Care Excellence (NICE) has recommended LUPKYNIS® (voclosporin) as
an option for treating adults with active lupus nephritis (LN)
class III, IV or V (including mixed class III/V and IV/V)1, when
provided in combination with mycophenolate mofetil (MMF).
The NICE recommendation applies to England and Wales and follows
the recent Medicines and Healthcare Products Regulatory Agency
(MHRA) authorization of voclosporin licensed in Great Britain for
the treatment of active LN in adult patients.
“We are extremely pleased with the NICE recommendation of
LUPKYNIS for patients with lupus nephritis. This recommendation
follows the earlier approval from the MHRA and further supports
access to an important treatment option for those patients. It also
emphasizes Aurinia’s commitment to providing meaningful therapy for
patients experiencing LN in key markets around the world,” said
Peter Greenleaf, President, and Chief Executive Officer of
Aurinia.
The NICE appraisal is based on the positive results from the
pivotal Phase 3 AURORA-1 study2,3 and the AURORA-2 continuation
study4, which demonstrated voclosporin, in combination with MMF and
low-dose corticosteroids, led to statistically superior complete
renal response rates at 52 weeks compared to MMF and low-dose
corticosteroids alone, and maintained stable eGFR (estimated
glomerular filtration rate) over 3 years. The safety profile of
voclosporin and MMF and low-dose corticosteroids was generally
comparable to MMF and low-dose corticosteroids alone.
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 people with SLE are four
times more likely to develop LN and people of Hispanic ancestry are
approximately twice as likely to develop the disease when compared
with White people. Black and Hispanic people with SLE also tend to
develop LN earlier and have poorer outcomes when compared to White
people.
About LUPKYNIS
LUPKYNIS® is the first U.S. FDA- and European
Commission-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 with a high unmet medical need that are impacted by
autoimmune, kidney and rare diseases. 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 Edmonton, Alberta,
its U.S. commercial office is in Rockville, Maryland. 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.
References
- NICE. Voclosporin with mycophenolate mofetil for treating lupus
nephritis [ID3962]. Available from:
https://www.nice.org.uk/guidance/gid-ta10878/documents/html-content-5
(Last accessed: April 2023).
- Rovin BH, Teng YKO, Ginzler EM, et al. Efficacy and safety of
voclosporin versus placebo for lupus nephritis (AURORA 1): a
double-blind, randomised, multicentre, placebo-controlled, phase 3
trial. Lancet. 2021;397(10289):2070–2080.
- ClinicalTrials.gov. Aurinia Renal Response in Active Lupus With
Voclosporin (AURORA). NCT03021499. Available from:
https://clinicaltrials.gov/ct2/show/NCT03021499 (Last accessed:
April 2023).
- ClinicalTrials.gov. Aurinia Renal Assessments 2: Aurinia Renal
Response in Lupus With Voclosporin (AURORA2), NCT03597464.
Available from: https://clinicaltrials.gov/ct2/show/NCT03597464
(Last accessed: April 2023).
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version on businesswire.com: https://www.businesswire.com/news/home/20230503005571/en/
Investor/Media Contact: Aurinia@westwicke.com
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