Aurinia Announces Japan Approval of LUPKYNIS® (Voclosporin) to Treat Lupus Nephritis
Aurinia Pharmaceuticals Inc - Common Shares (AUPH)
Last aurinia pharmaceuticals inc - common shares earnings: 3/5 04:02 pm
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Source: Business Wire
ROCKVILLE, Md. & EDMONTON, Alberta--(BUSINESS WIRE)--Aurinia Pharmaceuticals Inc. (NASDAQ: AUPH) (Aurinia or the Company) today announced that the Japanese Ministry of Health, Labour, and Welfare has approved voclosporin, a second-generation calcineurin inhibitor, in combination with mycophenolate mofetil (MMF) to treat lupus nephritis (LN).The Company’s collaboration partner, Otsuka Pharmaceutical Co., Ltd., filed the new drug application (NDA) with Japanese regulatory authorities in November 2023. The approval is based on data from the AURORA Clinical Program, which included a 12-month, Phase 3, double-blind, randomized-controlled study, as well as a two-year extension study, assessing the efficacy and safety of voclosporin with MMF and low-dose glucocorticoids, compared to MMF and low-dose glucocorticoids alone, in LN patients.“We are thrilled to achieve this milestone that will provide access to LUPKYNIS in Japan, where there is a high rate of lupus nephritis among Japanese lu
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News
- Aurinia Commends 2024 Updated ACR Guidelines for Screening, Treatment, and Management of Lupus Nephritis [Yahoo! Finance]Yahoo! Finance
- Aurinia Commends 2024 Updated ACR Guidelines for Screening, Treatment, and Management of Lupus NephritisBusiness Wire
- Aurinia Presents New Data Underscoring Critical Importance of Earlier Lupus Nephritis Detection and Intervention and Value of LUPKYNIS® in Managing LN at American College of Rheumatology Convergence 2024Business Wire
- Aurinia to Participate in Jefferies London Healthcare Conference [Yahoo! Finance]Yahoo! Finance
- Aurinia to Participate in Jefferies London Healthcare ConferenceBusiness Wire
AUPH
Earnings
- 11/7/24 - Beat
AUPH
Sec Filings
- 11/14/24 - Form SC
- 11/12/24 - Form 4
- 11/12/24 - Form 4
- AUPH's page on the SEC website