British Columbia-based Aurinia Pharmaceuticals Inc. announced today (July 22) that its voclosporin drug has been recommended for marketing authorization to treat adults with active lupus nephritis (LN).
The Canadian biopharma company said it is committed to delivering therapeutics that change the course of autoimmune disease after the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion for its Lupkynis. This is in combination with a background immunosuppressive therapy regimen to treat patients with active LN. LN is a serious complication of systemic lupus erythematosus (SLE).
The U.S. Food and Drug Administration (FDA) approved Lupkynis (voclosporin) on January 22, 2021, in combination with a background immunosuppressive therapy regimen to treat adult patients with active LN.
In December 2020, Aurinia entered into a collaboration and licensing agreement with Otsuka Pharmaceutical Co., Ltd., (Otsuka) for the development and commercialization of voclosporin for the treatment of LN in the European Union, Japan, the United Kingdom, Russia, Switzerland, Norway, Belarus, Iceland, Liechtenstein, and Ukraine.
In June 2021, Otsuka’s European subsidiary, Otsuka Pharmaceutical Europe Ltd. (OPEL), an affiliate of the company, filed an initial Marketing Authorization Application (MAA) for voclosporin for the treatment of LN to the EMA. In February 2022, Swiss Medic granted Otsuka orphan drug status for voclosporin in LN.
“I am proud of the outstanding efforts of our Aurinia submission team to prepare the MAA filing to secure this positive opinion and the strong collaboration between Aurinia and Otsuka to advance efforts to reach patient communities globally with this promising, important medicine,” said Sue Evans, vice president, global regulatory affairs, at Aurinia.
Based on the CHMP recommendation, a decision by the European Commission (EC) is expected in approximately two months. If granted by the EC, the centralized marketing authorization would be valid in all EU member states as well as in Iceland, Liechtenstein, and Norway.
Peter Greenleaf, president and CEO at Aurinia, said: “This positive recommendation brings us one step closer to delivering voclosporin to LN patients across Europe and with a strong history of commercialization in rare kidney disease, Otsuka is an ideal partner to bring voclosporin to patients to this market.”
The positive opinion from CHMP is based on the results of the pivotal Phase 3 AURORA 1 study and the recent AURORA 2 continuation study, which demonstrated voclosporin was safe and well tolerated in adults with LN for up to three years of treatment with no new safety signals and stable renal function.
Robert McQuade, executive vice president at Otsuka Pharmaceutical said: “Helping patients affected by kidney disease, an area that until recently has not experienced the scientific advances of some other disease areas, has been a core priority for Otsuka and Aurinia. With lupus nephritis affecting at least four out of 100,000 people in Europe, the CHMP’s positive recommendation for regulatory approval of voclosporin is an important step forward in the application of the recent science to bring new treatment options to more patients.”