Thursday, May 04, 2023
Aurinia Pharmaceuticals Inc., 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).
The 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.
“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.
The 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.