LUPKYNIS | Jotup

Aurinia Announces Updated Interim Results from the AURORA 2 Continuation Study of LUPKYNIS (voclosporin) for the Treatment of Lupus Nephritis

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月曜日, 11月 1, 2021

Biotechnology, Pharmaceutical, Health, Clinical Trials, Lupus Nephritis, LUPKYNIS, Aurinia, LUPUS NEPHRITIS, LUPKYNIS, AURINIA

The consistent outcomes over time reinforce confidence in LUPKYNIS as an important treatment choice for people experiencing the dangerous manifestation of lupus nephritis.

Key Points:

The consistent outcomes over time reinforce confidence in LUPKYNIS as an important treatment choice for people experiencing the dangerous manifestation of lupus nephritis.
Results from the completed Phase 3 randomized, double-blind, placebo-controlled, multicenter AURORA 1 study (NCT03021499) were recently published in The Lancet .
Lupus nephritis (LN) is a serious manifestation of systemic lupus erythematosus (SLE), a chronic and complex autoimmune disease.
LUPKYNIS is the first FDA-approved oral medicine for the treatment of adult patients with active lupus nephritis (LN).

Aurinia Pharmaceuticals to Present Five Abstracts at ASN Kidney Week 2021 and ACR Convergence 2021

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火曜日, 10月 26, 2021

Biotechnology, Pharmaceutical, Health, Other Health, Lupus Nephritis, LUPKYNIS, Aurinia, LUPUS NEPHRITIS, LUPKYNIS, AURINIA

ASN Kidney Week will take place virtually on November 2-7 and ACR Convergence will take place virtually on November 3-9.

Key Points:

ASN Kidney Week will take place virtually on November 2-7 and ACR Convergence will take place virtually on November 3-9.
The accepted abstract presentations and posters are listed below and can be viewed virtually from November 4-6 at ASN and from November 8-9 at ACR .
About 200,000-300,000 people live with SLE in the U.S. and approximately one out of three of these individuals develop LN.
If poorly controlled, LN can lead to permanent and irreversible tissue damage within the kidney, resulting in kidney failure.

Aurinia Announces Additional Analysis of its AURORA 1 Phase 3 Study Data Presented at ERA-EDTA 2021 Congress

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月曜日, 6月 7, 2021

About 200,000-300,000 people live with SLE in the U.S. and approximately one out of three of these individuals develop LN.

Key Points:

About 200,000-300,000 people live with SLE in the U.S. and approximately one out of three of these individuals develop LN.
If poorly controlled, LN can lead to permanent and irreversible tissue damage within the kidney, resulting in kidney failure.
Black and Hispanic individuals with SLE also tend to develop LN earlier and have poorer outcomes when compared to Caucasian individuals.
The recommended starting dose of LUPKYNIS is three capsules twice daily with no requirement for serum drug monitoring.

Aurinia To Present Supportive AURORA 2 Continuation Study Interim Analysis Demonstrating Long-Term Safety & Efficacy of LUPKYNIS™ (voclosporin) in Subjects with Lupus Nephritis

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木曜日, 5月 20, 2021

The interim analysis to be presented at EULAR evaluated subjects with up to two years of total treatment: one year from AURORA 1 and up to one year in AURORA 2.

Key Points:

The interim analysis to be presented at EULAR evaluated subjects with up to two years of total treatment: one year from AURORA 1 and up to one year in AURORA 2.
Data from 124 subjects (73 voclosporin; 51 control arm) who had received 104 weeks of continuous treatment was analyzed.
A greater reduction in proteinuria between arms was also observed between 1 and 2 years (1.0 vs 0.6 mg/mg; voclosporin vs control).
Renal function as determined by eGFR remained stable over 104 weeks in both groups compared to baseline assessments.

Aurinia Announces Publication of AURORA 1 Phase 3 Study Results with LUPKYNIS™ (voclosporin) in The Lancet

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月曜日, 5月 10, 2021

Biotechnology, Pharmaceutical, Health, Clinical trials, Clinical research, Pharmaceutical industry, Health sciences, Epidemiology, Drug Safety, Serious adverse event, Infection, Health, Life sciences, Lupus Nephritis, LUPKYNIS, Aurinia, LUPUS NEPHRITIS, LUPKYNIS, AURINIA

\xe2\x80\x9cThe publication of AURORA 1 data validates the importance of voclosporin (LUPKYNIS) in early disease intervention for LN.

Key Points:

\xe2\x80\x9cThe publication of AURORA 1 data validates the importance of voclosporin (LUPKYNIS) in early disease intervention for LN.
Serious adverse events (SAEs) were reported in 21% of those treated with LUPKNYIS and in 21% of those in the control group.
Infection and infestations were the most commonly reported SAEs, in 10% of the LUPKYNIS group and 11% of the control group.
Overall mortality in the AURORA 1 trial was low, with six deaths observed; one in the LUPKYNIS group and five in the control group.

Aurinia Presents Data Demonstrating LUPKYNIS™ (voclosporin) Efficacy Across Lupus Nephritis Biopsy Classes at National Kidney Foundation 2021 Spring Clinical Meetings

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木曜日, 4月 8, 2021

Aurinia Pharmaceuticals Inc. (NASDAQ: AUPH / TSX: AUP) (Aurinia or the Company) today presented additional efficacy data from the AURA-LV and AURORA 1 pivotal trials of LUPKYNIS (voclosporin) in lupus nephritis (LN).

Key Points:

Aurinia Pharmaceuticals Inc. (NASDAQ: AUPH / TSX: AUP) (Aurinia or the Company) today presented additional efficacy data from the AURA-LV and AURORA 1 pivotal trials of LUPKYNIS (voclosporin) in lupus nephritis (LN).
The data were shared at the National Kidney Foundation (NKF) 2021 Spring Clinical Meetings by Anca D. Askanase, M.D., M.P.H., Founder and Director of Columbia University Irving Medical Centers Lupus Center and the Director of Rheumatology Clinical Trials.
The clinical trials were not powered to detect a significant difference between the two treatment arms by biopsy class.
If poorly controlled, LN can lead to permanent and irreversible tissue damage within the kidney, resulting in kidney failure.

Aurinia Announces Positive Cost-Effectiveness Assessment of LUPKYNIS™ (voclosporin) in Latest ICER Draft Evidence Report

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月曜日, 3月 15, 2021

The ICER report determined LUPKYNIS to be more cost-effective across several sub-groups of LN patient populations, including black patients, compared to the general population, which ICER notes could have the potential to reduce historic disparities.

Key Points:

The ICER report determined LUPKYNIS to be more cost-effective across several sub-groups of LN patient populations, including black patients, compared to the general population, which ICER notes could have the potential to reduce historic disparities.
ICERs assessment of LUPKYNIS is consistent with the real-world view of LUPKYNIS value we are hearing during our positive interactions with both physicians and payers during the first two months since our launch, said Peter Greenleaf, Chief Executive Officer of Aurinia Pharmaceuticals.
ICER is an independent non-profit research organization that evaluates the evidence on the clinical and economic value of prescription drugs, medical tests, devices, and health system delivery innovations.
The report will next be evaluated by the ICER Council before the organization issues its final Evidence Report.