Otsuka Submits New Drug Application in Japan for 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
EDMONTON, Alberta--(BUSINESS WIRE)--Aurinia Pharmaceuticals Inc. (NASDAQ: AUPH) (Aurinia or the Company) today announced three oral presentations at the Annual Meeting of the European Renal Association (ERA), providing additional support for the efficacy and safety of LUPKYNIS® (voclosporin), a next generation calcineurin inhibitor (CNI) approved in the U.S. and Europe for the treatment of adults with active lupus nephritis (LN).
EDMONTON, Alberta--(BUSINESS WIRE)--Aurinia Pharmaceuticals Inc. (NASDAQ: AUPH) (Aurinia or the Company) today announced the results of a post-hoc, pooled analysis of the Phase 2 AURA-LV (NCT02141672) and Phase 3 AURORA 1 (NCT03021499) studies, which found that LUPKYNIS® with mycophenolate mofetil (MMF) and low-dose steroids resulted in earlier and greater reductions in proteinuria in lupus nephritis (LN) patients with high proteinuria across biopsy classes, races, and ethnicities. These data were presented at the European Congress of Rheumatology, EULAR 2023, in Milan, Italy.
LONDON, UK, 3 May 2023 – Otsuka Pharmaceuticals (U.K.) Ltd. announces that the National Institute for Health and Care Excellence (NICE) has recommended Lupkynis® (voclosporin) in combination with mycophenolate mofetil (MMF) as an option for treating adults with active lupus nephritis (LN) class III, IV or V (including mixed class III/V and IV/V), when provided as a commercially arranged patient access scheme1.
EDMONTON, Alberta--(BUSINESS WIRE)--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).
EDMONTON, Alberta--(BUSINESS WIRE)--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.
Aurinia Pharmaceuticals Announces New and Refined Method of Use Patent for LUPKYNIS® in the Treatment of Lupus Nephritis Issued by United States Patent and Trademark Office
Aptalis Pharma`s Lupkynis (Voclosporin) Approved In Europe
Aurinia Pharmaceuticals Announces Allowance of a New and Refined Method of Use Patent for LUPKYNIS® in the Treatment of Lupus Nephritis From the United States Patent and Trademark Office