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Aurinia Pharmaceuticals Announces NICE Recommendation of LUPKYNIS® (Voclosporin) For Adults with Active Lupus Nephritis
EDMONTON, Alberta--(BUSINESS WIRE)-- Aurinia Pharmaceuticals Inc. (NASDAQ: AUPH) (Aurinia or the Company) today announced that the National Institute for
About this update from Aurinia Pharmaceuticals Inc
[{"type":"text","content":" EDMONTON, Alberta--(BUSINESS WIRE)--\nAurinia Pharmaceuticals Inc. (NASDAQ: AUPH) (Aurinia or the Company) today announced that the National Institute for Health and Care Excellence (NICE) has recommended LUPKYNIS® (voclosporin) as an option for treating adults with active lupus nephritis (LN) class III, IV or V (including mixed class III/V and IV/V)1, when provided in combination with mycophenolate mofetil (MMF).\n\n\nThe NICE recommendation applies to England and Wales and follows the recent Medicines and Healthcare Products Regulatory Agency (MHRA) authorization of voclosporin licensed in Great Britain for the treatment of active LN in adult patients.\n\n\n“We are extremely pleased with the NICE recommendation of LUPKYNIS for patients with lupus nephritis. This recommendation follows the earlier approval from the MHRA and further supports access to an important treatment option for those patients. It also emphasizes Aurinia’s commitment to providing meaningful therapy for patients experiencing LN in key markets around the world,” said Peter Greenleaf, President, and Chief Executive Officer of Aurinia.\n\n\nThe NICE appraisal is based on the positive results from the pivotal Phase 3 AURORA-1 study2,3 and the AURORA-2 continuation study4, which demonstrated voclosporin, in combination with 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.\n\n\nAbout Lupus Nephritis\n\n\nLN is a serious manifestation of 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, LN can lead to permanent and irreversible tissue damage within the kidney. Black and Asian people with SLE are four times more likely to develop LN and people of Hispanic ancestry are approximately twice as likely to develop the disease when compared with White people. Black and Hispanic people with SLE also tend ...