Approval follows the positive opinion granted by European Committee for Medicinal Products for Human Use (CHMP) in July 2022
LUPKYNIS is the first oral medicine approved in both the U.S. and Europe for the treatment of adults living with active lupus nephritis
Approval triggers $30.0 million milestone payment, to be recognized as revenue in the 3rd quarter
Aurinia Pharmaceuticals Inc. (NASDAQ:AUPH) (Aurinia or the Company), a biopharmaceutical company committed to delivering therapeutics that change the trajectory of autoimmune disease, announced that the European Commission (EC) has granted marketing authorization of LUPKYNIS (voclosporin) to treat adults with active lupus nephritis (LN), a serious complication of systemic lupus erythematosus (SLE). The U.S. Food and Drug Administration (FDA) approved LUPKYNIS on January 22, 2021, in combination with a background immunosuppressive therapy regimen to treat adult patients with active LN.
The centralized marketing authorization is valid in all European Union (EU) member states as well as in Iceland, Liechtenstein, Norway and Northern Ireland.
"Today marks the first approved oral treatment for lupus nephritis in both the European Union and provides adults across Europe living with this potentially life-threatening disease a new treatment option," said Peter Greenleaf, President and Chief Executive Officer, Aurinia. "People with lupus nephritis and their physicians have long been challenged by the lack of treatments available. In partnership with Otsuka, we're excited to reach patients across Europe with a meaningful therapy that can help enable positive long-term kidney outcomes."
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 EU, Japan, the United Kingdom, Russia, Switzerland, Norway, Belarus, Iceland, Liechtenstein, and Ukraine. As part of the agreement, Aurinia will receive a $30.0 million EC approval-related milestone payment to be recognized as revenue in the quarter, with receipt of cash to follow within 30 days of invoicing. In addition to the milestone payment, Aurinia is eligible to receive further payments tied to additional regulatory and reimbursement milestones, low double-digit royalties on future net sales, as well as revenues for the supply of product to Otsuka under a cost-plus arrangement.
A decision on marketing authorization for LUPKYNIS in Great Britain is expected from the UK Medicines and Healthcare products Regulatory Agency in the coming weeks. In addition, a marketing authorization application (MAA) 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.
The EC approval of LUPKYNIS is based on the results of the pivotal Phase 3 AURORA 1 study and the recent 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.