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Aurinia Announces the Great Britain Marketing Authorization of LUPKYNIS (voclosporin) for the Treatment of Lupus Nephritis
Wednesday, December 7, 2022Company Profile | Follow Company
MHRA Approval follows European Commission marketing authorization of LUPKYNIS to treat adults with active lupus nephritis in 27 European Union Member States
LUPKYNIS is the first oral medicine approved in the U.S. and Europe for the treatment of adults living with active lupus nephritis
Victoria, BC, December 7, 2022--(T-Net)--Aurinia Pharmaceuticals Inc. (NASDAQ:AUPH), a biopharmaceutical company committed to delivering therapeutics that change the trajectory of autoimmune disease, announced that the U.K. Medicines and Healthcare products Regulatory Agency (MHRA) has granted the Great Britain marketing authorization of LUPKYNIS (voclosporin) to treat adults with active lupus nephritis (LN), a serious complication of systemic lupus erythematosus (SLE).
Peter Greenleaf, Chief Executive Officer, Director, Aurinia Pharmaceuticals Inc.
"The MHRA authorization of LUPKYNIS for individuals with lupus nephritis in Great Britain, on the heels of the marketing authorization in the EU, further expands the availability of LUPKYNIS as a treatment option for people with lupus nephritis," said Peter Greenleaf, President and Chief Executive Officer, Aurinia. "Otsuka has been a valued partner in these efforts, and we are pleased to work with them to reach new patients."
The marketing authorization by the MHRA, which follows the European Commission (EC) authorization on September 19, 2022, 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.
The safety profile of voclosporin and MMF and low-dose corticosteroids was generally comparable to MMF and low-dose corticosteroids alone.
In addition, a marketing authorization application for LUPKYNIS was submitted to the Swiss Agency for Therapeutic Products (Swissmedic) and is currently under review. Swissmedic previously granted orphan drug status to voclosporin in LN in February 2022.
Aurinia and Otsuka Pharmaceutical Co., Ltd., (Otsuka) entered a collaboration and licensing agreement in December 2020 for the development and commercialization of voclosporin for the treatment of LN in the United Kingdom, EU, Japan, Russia, Switzerland, Norway, Belarus, Iceland, Liechtenstein, and Ukraine.
About Lupus Nephritis
LN is a serious manifestation of 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, LN can lead to permanent and irreversible tissue damage within the kidney. Black and Asian individuals with SLE are four times more likely to develop LN and individuals of Hispanic ancestry are approximately twice as likely to develop the disease when compared with Caucasian individuals. Black and Hispanic individuals with SLE also tend to develop LN earlier and have poorer outcomes when compared to Caucasian individuals.
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 that are impacted by serious diseases with a high unmet medical need. In January 2021, the Company introduced LUPKYNIS® (voclosporin), the first FDA-approved oral therapy dedicated for the treatment of adult patients with active lupus nephritis. The Company's head office is in Victoria, British Columbia, its U.S. commercial office is in Rockville, Maryland. The Company focuses its development efforts globally.
Forward-Looking Statements Certain statements made in this press release may constitute forward-looking information within the meaning of applicable Canadian securities law and forward-looking statements within the meaning of applicable United States securities law. These forward-looking statements or information include but are not limited to statements or information with respect to: Aurinia's estimates as to annual net revenue; Aurinia's estimates as to the number of patients with SLE in the U.S. and the proportion of those persons who will develop LN; Aurinia being confident that it is well-poised for growth; Aurinia's belief that it has sufficient financial resources to fund its current plans; the expected timing for the EMA CHMP opinion and EMA decision relating to the EMA MAA; and the planned timing for reporting top-line results from the ongoing AURORA-2 continuation study. [ MORE ] |
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