Voclosporin

Long Term Phase 3 Data Published in Arthritis & Rheumatology Shows LUPKYNIS® (voclosporin) Preserved Kidney Function Up to Three Years in Lupus Nephritis Patients with No New or Unexpected Adverse Events

Retrieved on: 
Wednesday, July 19, 2023

“Proteinuria, a defining part of the characterization of chronic kidney disease, often precedes a decline in kidney function and is associated with progression to kidney failure.

Key Points: 
  • “Proteinuria, a defining part of the characterization of chronic kidney disease, often precedes a decline in kidney function and is associated with progression to kidney failure.
  • Reductions in proteinuria are critical for slowing or stopping progression to end-stage kidney disease and improving long-term outcomes for LN patients.
  • Notably, in this extension study, kidney preservation, sustained renal response, and reductions in steroid use were achieved with voclosporin.
  • We are proud of our sustained research in autoimmune diseases like lupus and remain committed to helping improve kidney health for people living with lupus nephritis.”

Major Shifts in Management of Patients with Lupus Nephritis Spurred by Availability of Aurinia Pharmaceutical's Lupkynis and GSK's Benlysta, According to Spherix Global Insights

Retrieved on: 
Friday, January 20, 2023

EXTON, Pa., Jan. 20, 2023 /PRNewswire/ -- With the approvals of GlaxoSmithKline's Benlysta (belimumab) in lupus nephritis (LN) at the end of 2020 and Aurinia's Lupkynis (voclosporin) at the beginning of 2021, practitioners now have valuable new treatment options to battle this complex and serious condition.

Key Points: 
  • Spherix Global Insights has been a leader in tracking the lupus nephritis market for several years, covering physician perspectives, treatment patterns, and pipeline assessments.
  • Compared to the prior year (n=954 patients), use of Aurinia's novel calcineurin inhibitor expanded significantly, regardless of which specialty was managing the treatment regimen.
  • Use of Benlysta was relatively flat with rheumatology-managed patients being far more likely to be treated with the agent than nephrology-managed patients.
  • LN patients under nephrology management were three times as likely to be on an SGLT2 inhibitor compared to those under management of a rheumatologist.

Spherix Research Reveals Rheumatologists Taking the Lead Over Nephrologists in Both BENLYSTA (GlaxoSmithKline) and LUPKYNIS (Aurinia) Patient Initiations in Lupus Nephritis

Retrieved on: 
Friday, June 17, 2022

EXTON, Pa. , June 17, 2022 /PRNewswire/ -- With the approvals of GlaxoSmithKline's Benlysta in lupus nephritis (LN) at the end of 2020 and Aurinia's Lupkynis at the beginning of 2021, practitioners now have valuable new treatment options to battle this complex condition.

Key Points: 
  • This research, in collaboration with 50 US nephrologists and 50 US rheumatologists each month, reveals that specialists are responding differently to Benlysta and Lupkynis in both perception and use.
  • Analysis also includes insights on patient demographics, patient initiations, and discontinuations, while exploring co-management between nephrologists and rheumatologists.
  • Benlysta prevails with rheumatologists on patient adherence, tolerability, and safety, while nephrologists give the edge to Lupkynis on those exact same metrics.
  • Of note, nephrologists' view on Benlysta's "overall benefit" to LN patients versus Lupkynis has improved in the past six months.

Perceptions and Prescribing Patterns of GSK's Benlysta and Aurinia's Lupkynis Highlight an Increasing Divide Among Nephrologists and Rheumatologists, Spherix Finds

Retrieved on: 
Tuesday, December 14, 2021

Specialists' opinions diverge on key performance metrics between the two products as well, particularly on patient adherence, tolerability, monitoring, and safety with nephrologists favoring Lupkynis and rheumatologists favoring Benlysta.

Key Points: 
  • Specialists' opinions diverge on key performance metrics between the two products as well, particularly on patient adherence, tolerability, monitoring, and safety with nephrologists favoring Lupkynis and rheumatologists favoring Benlysta.
  • Rheumatologist
    "If the patient still has significant proteinuria [with SOC] that's usually when I add Lupkynis to the regimen.
  • Nephrologist
    "If the patient is having significant membranous changes, in addition to proliferative changes, and have severe proteinuria, I might add Lupkynis."
  • Lupkynis prescribing has also gradually increased, with rheumatologists taking a slight lead on prescribing overall, likely due to nephrologists' cost- and risk-benefit uncertainty compared to other options like tacrolimus.

Aurinia Announces Licensing Partner Otsuka Filed Initial Marketing Authorization Application (MAA) for Voclosporin with the European Medicines Agency (EMA)

Retrieved on: 
Friday, June 25, 2021

Aurinia Pharmaceuticals Inc. (NASDAQ: AUPH / TSX: AUP) (the Company) announced today that the Companys licensing partner, Otsuka Pharmaceutical Europe Ltd. (OPEL), filed an initial Marketing Authorization Application (MAA) for voclosporin for the treatment of lupus nephritis (LN) to the European Medicines Agency (EMA).

Key Points: 
  • Aurinia Pharmaceuticals Inc. (NASDAQ: AUPH / TSX: AUP) (the Company) announced today that the Companys licensing partner, Otsuka Pharmaceutical Europe Ltd. (OPEL), filed an initial Marketing Authorization Application (MAA) for voclosporin for the treatment of lupus nephritis (LN) to the European Medicines Agency (EMA).
  • Once the MAA is approved, OPEL would be authorized to market voclosporin in the European Union, Norway, Iceland, and Liechtenstein.
  • Lupus nephritis is a serious, complex condition that historically has lacked dedicated, approved treatment options, said Peter Greenleaf, President and Chief Executive Officer of Aurinia Pharmaceuticals.
  • If poorly controlled, LN can lead to permanent and irreversible tissue damage within the kidney, resulting in kidney failure.

Aurinia Pharmaceuticals to Present at the Jefferies Virtual Healthcare Conference

Retrieved on: 
Thursday, May 27, 2021

Aurinia Pharmaceuticals Inc. (NASDAQ: AUPH / TSX: AUP) (the Company) today announced that members of the executive management team will participate in a fireside chat during the Jefferies Virtual Healthcare Conference on Thursday, June 3, 2021 at 11:30 a.m.

Key Points: 
  • Aurinia Pharmaceuticals Inc. (NASDAQ: AUPH / TSX: AUP) (the Company) today announced that members of the executive management team will participate in a fireside chat during the Jefferies Virtual Healthcare Conference on Thursday, June 3, 2021 at 11:30 a.m.
  • In order to participate in the audio webcast, interested parties can access the live webcast under "News/Events through the Investors section of the Aurinia corporate website at www.auriniapharma.com .
  • 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.
  • The Company has introduced LUPKYNIS (voclosporin), the first FDA-approved oral therapy dedicated for the treatment of adult patients with active lupus nephritis (LN).

Aurinia Pharmaceuticals to Participate in Two Upcoming Investor Conferences

Retrieved on: 
Friday, May 14, 2021

b'Aurinia Pharmaceuticals Inc. (NASDAQ: AUPH / TSX: AUP) (the \xe2\x80\x9cCompany\xe2\x80\x9d) today announced that members of the executive management team will participate in two upcoming investor conferences:\nRBC Capital Markets Global Healthcare Conference on Wednesday, May 19, 2021 at 10:55 a.m.

Key Points: 
  • b'Aurinia Pharmaceuticals Inc. (NASDAQ: AUPH / TSX: AUP) (the \xe2\x80\x9cCompany\xe2\x80\x9d) today announced that members of the executive management team will participate in two upcoming investor conferences:\nRBC Capital Markets Global Healthcare Conference on Wednesday, May 19, 2021 at 10:55 a.m.
  • ET; and\nOppenheimer Rare & Orphan Disease Summit on Friday, May 21, 2021 at 10:45 a.m. ET.\nIn order to participate in the audio webcast, interested parties can access the live webcast under "News/Events\xe2\x80\x9d through the \xe2\x80\x9cInvestors\xe2\x80\x9d section of the Aurinia corporate website at www.auriniapharma.com .
  • The Company has introduced LUPKYNIS\xe2\x84\xa2 (voclosporin), the first FDA-approved oral therapy dedicated for the treatment of adult patients with active lupus nephritis (LN).
  • The Company\xe2\x80\x99s head office is in Victoria, British Columbia, its U.S. commercial hub is in Rockville, Maryland, and the Company focuses its development efforts globally.\nView source version on businesswire.com: https://www.businesswire.com/news/home/20210514005073/en/\n'

Aurinia Pharmaceuticals to Present at the Bloom Burton & Co. Healthcare Investor Conference

Retrieved on: 
Thursday, April 15, 2021

b'Aurinia Pharmaceuticals Inc. (NASDAQ: AUPH / TSX: AUP) (the \xe2\x80\x9cCompany\xe2\x80\x9d) today announced that members of the executive management team will participate in a fireside chat during the 2021 Bloom Burton & Co. Healthcare Investor Conference on Tuesday, April 20, 2021 at 2:30 p.m. ET.\nIn order to participate in the audio webcast, interested parties can access the live webcast under "News/Events\xe2\x80\x9d through the \xe2\x80\x9cInvestors\xe2\x80\x9d section of the Aurinia corporate website at www.auriniapharma.com .

Key Points: 
  • b'Aurinia Pharmaceuticals Inc. (NASDAQ: AUPH / TSX: AUP) (the \xe2\x80\x9cCompany\xe2\x80\x9d) today announced that members of the executive management team will participate in a fireside chat during the 2021 Bloom Burton & Co. Healthcare Investor Conference on Tuesday, April 20, 2021 at 2:30 p.m. ET.\nIn order to participate in the audio webcast, interested parties can access the live webcast under "News/Events\xe2\x80\x9d through the \xe2\x80\x9cInvestors\xe2\x80\x9d section of the Aurinia corporate website at www.auriniapharma.com .
  • A replay of the webcast will be available on Aurinia\xe2\x80\x99s website.\nAurinia 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.
  • The Company has introduced LUPKYNIS\xe2\x84\xa2 (voclosporin), the first FDA-approved oral therapy dedicated for the treatment of adult patients with active lupus nephritis (LN).
  • The Company\xe2\x80\x99s head office is in Victoria, British Columbia, its U.S. commercial hub is in Rockville, Maryland, and the Company focuses its development efforts globally.\nView source version on businesswire.com: https://www.businesswire.com/news/home/20210415005158/en/\n'

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

Retrieved on: 
Thursday, April 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.

Voclosporin: A Novel and Potentially Best-in-Class Calcineurin Inhibitor (CNI) - Global Emerging Insight and Market Forecast 2021-2030 - ResearchAndMarkets.com

Retrieved on: 
Thursday, March 11, 2021

Voclosporin is a novel and potentially best-in-class calcineurin inhibitor ("CNI") with clinical data in over 2,600 patients across indications.

Key Points: 
  • Voclosporin is a novel and potentially best-in-class calcineurin inhibitor ("CNI") with clinical data in over 2,600 patients across indications.
  • By inhibiting calcineurin, Voclosporin blocks IL-2 expression and T-cell mediated immune responses and stabilizes the podocyte in the kidney.
  • "Voclosporin - Emerging Insight and Market Forecast - 2030" the report provides comprehensive insights about an investigational product for Focal segmental glomerulosclerosis in 7 Major Markets.
  • Further, it also consists of future market assessments inclusive of the market forecast, SWOT analysis, market competitors, and other emerging therapies.