Aurinia Pharmaceuticals Inc. (NASDAQ: AUPH) (Aurinia or the
Company) today announced that the Swiss Agency for Therapeutic
Products (Swissmedic) has granted marketing authorization of
LUPKYNIS® (voclosporin) in combination with a background
immunosuppressive therapy to treat adults with active class III, IV
and V (including mixed classes III/V and IV/V) lupus nephritis
(LN), a serious complication of systemic lupus erythematosus (SLE).
In addition, we have received Orphan Drug designation in
Switzerland, granting 15 years of drug exclusivity protection in
association with approval.
“We are extremely pleased with the Swissmedic approval of
LUPKYNIS for adults with lupus nephritis. This approval provides
patients with an important treatment option and makes LUPKYNIS a
more accessible therapy for patients experiencing LN,” said Peter
Greenleaf, President, and Chief Executive Officer, Aurinia. “Otsuka
continues to be an important and valuable partner in our global
efforts.”
The marketing authorization by Swissmedic, 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, 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.
Aurinia and Otsuka Pharmaceutical Co., Ltd., (Otsuka) entered
into a collaboration and licensing agreement in December 2020 for
the development and commercialization of voclosporin for the
treatment of LN in the United Kingdom, European Union, Japan,
Russia, Switzerland, Norway, Belarus, Iceland, Liechtenstein, and
Ukraine.
About Lupus Nephritis
Lupus nephritis 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 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, lupus
nephritis can lead to permanent and irreversible tissue damage
within the kidney. Black and Asian people with SLE are four times
more likely to develop lupus nephritis and Hispanic people are
approximately twice as likely to develop the disease compared to
White people with SLE. Black and Hispanic people with SLE also tend
to develop lupus nephritis earlier and have poorer outcomes,
compared to White people with SLE.
About LUPKYNIS
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
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 for the treatment of adult patients with active lupus
nephritis (LN). The Company’s head office is in Edmonton, Alberta,
its U.S. commercial hub is in Rockville, Maryland, and 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.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20230502005938/en/
Investor/Media Contact: Aurinia@westwicke.com
Aurinia Pharmaceuticals (NASDAQ:AUPH)
Gráfico Histórico do Ativo
De Abr 2024 até Mai 2024
Aurinia Pharmaceuticals (NASDAQ:AUPH)
Gráfico Histórico do Ativo
De Mai 2023 até Mai 2024