Positive CHMP opinion is based on a comprehensive submission including data from the pivotal AURORA 1 efficacy study and the AURORA 2 continuation study, demonstrating voclosporin to be safe and well tolerated for up to three years of treatment.
Based on the CHMP recommendation, a decision by the European Commission is expected in approximately two months.
LUPKYNIS® was approved by the FDA in 2021 for the treatment of adults with active lupus nephritis and is the first oral therapy available for the treatment of the disease, in the U.S.
VICTORIA, British Columbia--(BUSINESS WIRE)-- Aurinia Pharmaceuticals Inc. (NASDAQ:AUPH) (Aurinia or the Company), a biopharmaceutical company committed to delivering therapeutics that change the course of autoimmune disease, today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion recommending voclosporin (brand name, LUPKYNIS) for marketing authorization to treat adults with active lupus nephritis (LN), 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 Otsuka, 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.
Based on the CHMP recommendation, a decision by the European Commission is expected in approximately two months. If granted by the European Commission, the centralized marketing authorization would be valid in all EU member states as well as in Iceland, Liechtenstein, and Norway.
“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,” said Peter Greenleaf, President and Chief Executive Officer, Aurinia.
“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, Aurinia.
Robert McQuade PhD, Executive Vice President and Chief Strategy Officer, Otsuka Pharmaceutical Development & Commercialization, Inc, noted, “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.”
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. The results of the AURORA 1 study were published in The Lancet and demonstrated that voclosporin, in combination with mycophenolate mofetil (MMF) and low-dose corticosteroids, led to statistically superior complete renal response rates at 52 weeks compared to treatment with MMF and low-dose corticosteroids alone. The study also showed statistically superior time to achieve a urine protein creatinine ratio (UPCR) of 3%) were glomerular filtration rate decreased, hypertension, diarrhea, headache, anemia, cough, urinary tract infection, abdominal pain upper, dyspepsia, alopecia, renal impairment, abdominal pain, mouth ulceration, fatigue, tremor, acute kidney injury, and decreased appetite.
SPECIFIC POPULATIONS Pregnancy/Lactation: May cause fetal harm. Advise not to breastfeed.
Renal Impairment: Not recommended in patients with baseline eGFR ≤45 mL/min/1.73 m2 unless benefit exceeds risk. Severe renal impairment: Reduce LUPKYNIS dose.
Mild and Moderate Hepatic Impairment: Reduce LUPKYNIS dose. Severe hepatic impairment: Avoid LUPKYNIS use.
Please see Prescribing Information, including Boxed Warning, and Medication Guide for LUPKYNIS.
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Media: Dana Lynch Corporate Communications, Aurinia dlynch@auriniapharma.com Investors: aurinia@westwicke.com
Source: Aurinia Pharmaceuticals Inc.