Aurinia Pharmaceuticals wins European approval.
Aurinia Pharmacueticals Inc is a well-known biopharmaceutical company that is committed to delivering therapeutics which will change the trajectory of autoimmune disease. They have announced that the European Commission has granted them marketing authorization of LUPKYNIS for treating adults with active lupus nephritis. Lupus nephritis is a severe complication of systemic lupus erythematosus.
The US Food and Drug Administration approved LUPKYNIS on January 22, 2021. They had approved this in combination with a background immunosuppressive therapy regimen to treat adult patients with active lupus nephritis. This approval marks the first approved oral treatment for lupus nephritis in European Union. It provides adults who are living across Europe with new treatment options for this potentially life-threatening disease.
This centralized marketing authorization would be valid in all European Union member states and Northern Ireland, Norway, Iceland, and Liechtenstein. Those suffering from lupus nephritis were challenged by a lack of treatment options for a long time. Peter Greenleaf is the President and Chief Executive Office of Aurinia. He had said with the partnership with Otsuka, and they are both excited to reach patients across Europe with a meaningful therapy that will enable positive long–term kidney outcomes.
Aurinia and Otsuka Pharmaceutical entered a collaboration and licensing agreement in December 2020 for the development and commercialization of voclosporin for treating LN in the EU, Russia, Japan, United Kingdom, Switzerland, Norway, Belarus, Iceland, Ukraine, and Liechtenstein. As per the agreement between both parties, Aurinia would receive a $30.0 million EC approval–related payment.
It will be recognized as quarterly revenue, with a cash receipt to follow within 30 days of invoicing. Further to the milestone payment, Aurinia would also be eligible to receive further payments, which would be tied to the additional regulatory and reimbursement milestones and low double-digit royalties on the future net sales as well as revenues for the supply of products to Otsuka under a cost-plus arrangement.
The decision on marketing authorization for LUPKYNIS in Great Britain is expected in the coming weeks from the UK Medicines and Healthcare products Regulatory Agency.
Featured Image Credit: Banksdetail.com