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Aurinia Pharmaceuticals Announces Swissmedic Approval of LUPKYNIS (Voclosporin), Receives 15 Years of Drug Exclusivity Protection (Orphan Drug)
Wednesday, May 10, 2023Company Profile | Follow Company
Victoria, BC, May 10, 2023--(T-Net)--Aurinia Pharmaceuticals Inc. (NASDAQ: AUPH) 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.
Peter Greenleaf, Chief Executive Officer, Director, Aurinia Pharmaceuticals Inc.
"We are extremely pleased with the Swissmedic approval of LUPKYNIS for adults with lupus nephritis. This approval provides patients with an important treatment option and makes LUPKYNIS a more accessible therapy for patients experiencing LN," said Peter Greenleaf, President, and Chief Executive Officer, Aurinia. "Otsuka continues to be an important and valuable partner in our global efforts."
The marketing authorization by Swissmedic, 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, and maintained stable eGFR (estimated glomerular filtration rate) over 3 years. The safety profile of voclosporin and MMF and low-dose corticosteroids was generally comparable to MMF and low-dose corticosteroids alone.
Aurinia and Otsuka Pharmaceutical Co., Ltd., (Otsuka) entered into a collaboration and licensing agreement in December 2020 for the development and commercialization of voclosporin for the treatment of LN in the United Kingdom, European Union, Japan, Russia, Switzerland, Norway, Belarus, Iceland, Liechtenstein, and Ukraine.
About Lupus Nephritis
Lupus nephritis is a serious manifestation of systemic lupus erythematosus (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, lupus nephritis can lead to permanent and irreversible tissue damage within the kidney. Black and Asian people with SLE are four times more likely to develop lupus nephritis and Hispanic people are approximately twice as likely to develop the disease compared to White people with SLE. Black and Hispanic people with SLE also tend to develop lupus nephritis earlier and have poorer outcomes, compared to White people with SLE.
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 with a high unmet medical need that are impacted by autoimmune, kidney and rare diseases. In January 2021, the Company introduced LUPKYNIS® (voclosporin), the first FDA-approved oral therapy for the treatment of adult patients with active lupus nephritis (LN). The Company's head office is in Edmonton, Alberta, its U.S. commercial hub is in Rockville, Maryland, and 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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