Aurinia's LUPKYNIS® Approved in Japan for Lupus Nephritis

Aurinia Pharmaceuticals Inc. (NASDAQ: AUPH) has announced that the Japanese Ministry of Health, Labour, and Welfare has approved voclosporin, marketed under the brand name LUPKYNIS, for the treatment of lupus nephritis (LN) in combination with mycophenolate mofetil (MMF). The approval follows the submission of a new drug application (NDA) by Otsuka Pharmaceutical Co., Ltd., Aurinia’s strategic partner, in November 2023.

The approval of voclosporin in Japan is based on the robust data from the AURORA Clinical Program. This program included a 12-month Phase 3, double-blind, randomized-controlled study, as well as a two-year extension study. These studies evaluated the efficacy and safety of voclosporin combined with MMF and low-dose glucocorticoids versus the use of MMF and low-dose glucocorticoids alone in patients with LN.

Peter Greenleaf, President and Chief Executive Officer of Aurinia, expressed his enthusiasm about the approval, highlighting the significant impact it will have on Japanese patients suffering from LN. He also emphasized the success of Aurinia’s partnership with Otsuka, which has been instrumental in bringing LUPKYNIS to patients in Europe and now Japan. This partnership was established in December 2020 and covers the development and commercialization of oral voclosporin in multiple regions including the EU, Japan, and others. Under this agreement, Aurinia will receive a $10 million payment upon approval in Japan and will earn low double-digit royalties on net sales post-launch. Additionally, Aurinia will supply the product to Otsuka to support the launch.

Voclosporin was previously approved in January 2021 by the U.S. Food and Drug Administration (FDA) for use in combination with a background immunosuppressive therapy regimen, specifically for adult patients with active lupus nephritis. It is available in the U.S. under the brand name LUPKYNIS.

Lupus nephritis is a severe manifestation of systemic lupus erythematosus (SLE), an autoimmune disease that can lead to kidney damage. LN affects about 120,000 people in the U.S., with a higher prevalence among women and people of color. Proper management of LN is critical, as inadequate control can result in irreversible kidney damage. Current medical guidelines recommend regular screening for LN in all SLE patients. However, research indicates that approximately 50% of SLE patients are not screened, and 77% of those with LN remain untreated. Aurinia is committed to improving health outcomes for people with LN by enhancing awareness and encouraging routine screenings and the use of effective therapies.

LUPKYNIS, a second-generation calcineurin inhibitor (CNI), functions by suppressing T-cell activation and cytokine production while promoting kidney podocyte stability. The AURORA Clinical Program has been pivotal in demonstrating the effectiveness of LUPKYNIS combined with standard care in preserving kidney health in patients with active LN without the need for chronic high-dose glucocorticoids. This program is unique in its inclusion of three years of treatment and follow-up for LN patients using MMF and steroids.

Aurinia Pharmaceuticals is dedicated to developing therapies for autoimmune diseases with high unmet medical needs. Besides LUPKYNIS, Aurinia is advancing AUR200, a promising therapy targeting BAFF (B-cell Activating Factor) and APRIL (A Proliferation-Inducing Ligand) for treating autoimmune diseases.

In summary, the approval of voclosporin in Japan marks a significant advancement in the treatment of lupus nephritis, providing a new therapeutic option for patients in need. Aurinia’s continued efforts and collaborations highlight its commitment to addressing the critical needs of those affected by autoimmune diseases.