Aurinia Pharmaceuticals Announces Swissmedic Approval of LUPKYNIS (voclosporin)

Aurinia Pharmaceuticals Inc. (NASDAQ: AUPH) (Aurinia or the Company) 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.

“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.