The positive CHMP opinion is based on a comprehensive submission including data from the AURORA 1 pivotal efficacy study and the AURORA 2 continuation study, demonstrating that voclosporin is safe and well tolerated for up to three years of treatment.
Based on the CHMP recommendation, a decision from the European Commission is expected in about two months.
WOLFKYNIS ® 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 United States
Aurinia Pharmaceuticals Inc. (NASDAQ: AUPH) (Aurinia or the Company), a biopharmaceutical company engaged in providing disease-modifying therapeutics for autoimmune diseases, today announced that the Human Medicinal Products Committee (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending the marketing authorization of voclosporin (brand name LUPKYNIS) for the treatment of adults with active lupus nephritis (LN), a serious complication of systemic lupus erythematosus (SLE). The United States 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 license agreement with Otsuka Pharmaceutical Co., Ltd., (Otsuka) for the development and commercialization of voclosporin for the treatment of LN in the European Union, Japan, in the United Kingdom, Russia, Switzerland, Norway, Belarus, Iceland, Liechtenstein and Ukraine. In June 2021, Otsuka’s European subsidiary, Otsuka Pharmaceutical Europe Ltd. (OPEL), a subsidiary of Otsuka, has filed a first marketing authorization application (MA) for voclosporin for the treatment of LN with the EMA. In February 2022, Swiss Medic granted Otsuka orphan drug status for voclosporin in LN.
Based on the CHMP recommendation, a decision from the European Commission is expected in about two months. If granted by the European Commission, the centralized marketing authorization would be valid in all EU member states as well as Iceland, Liechtenstein and Norway.
“This positive recommendation brings us one step closer to delivering voclosporin to LN patients across Europe and with a strong commercialization history in rare kidney diseases, Otsuka is an ideal partner to bring voclosporin to patients in this market. said Peter Greenleaf, President and Chief Executive Officer, Aurinia.
“I am proud of the outstanding efforts of our Aurinia submissions team to prepare the MA dossier for this positive review and the close collaboration between Aurinia and Otsuka to advance efforts to reach patient communities. around the world with this promising and important drug,” said Sue Evans. , Vice President, Global Regulatory Affairs, Aurinia.
Robert McQuade PhD, Executive Vice President and Chief Strategy Officer, Otsuka Pharmaceutical Development & Commercialization, Inc, said, “Helping patients with kidney disease, an area that until recently has not seen the advances scientists from certain other disease areas, has been a key priority for Otsuka and Aurinia. With lupus nephritis affecting at least four in 100,000 people in Europe, the positive CHMP recommendation for regulatory approval of voclosporin is an important step forward in applying recent science to bring new treatment options to more patients .”
The positive CHMP opinion is based on results from the pivotal Phase 3 AURORA 1 study and the recent AURORA 2 continuation study, which demonstrated that voclosporin was safe and well tolerated in adults with LN for up to at three years of treatment with no new safety signals and stable kidney function. The results of the AURORA 1 study have been published in The Lancet and demonstrated that voclosporin, in combination with mycophenolate mofetil (MMF) and low-dose corticosteroids, resulted in statistically higher renal complete response rates at 52 weeks compared to treatment with MMF and low-dose corticosteroids alone. The study also showed a statistically superior time to reach a urinary protein-creatinine ratio (UPCR) recently presented at the 59th Congress of the European Kidney Association (ERA) and the European Congress of Rheumatology, European Alliance of Rheumatology Associations (EULAR ) 2022 .
About Lupus Nephritis
LN is a severe manifestation of SLE, a chronic and complex autoimmune disease. Approximately 200,000 to 300,000 people live with SLE in the United States, and approximately one-third of these people are diagnosed with lupus nephritis at the time of their diagnosis of SLE. About 50% of all people with SLE can develop LN. If poorly controlled, LN can lead to permanent and irreversible tissue damage in the kidney. Black and Asian people with SLE are four times more likely to develop LN, and people of Hispanic descent are about twice as likely to develop the disease as Caucasians. Black and Hispanic people with SLE also tend to develop LN earlier and have poorer outcomes compared to Caucasians.
WOLFKYNIS ® is the first oral drug approved by the US FDA for the treatment of adult patients with active lupus nephritis (LN). LUPKYNIS is a novel structurally modified calcineurin inhibitor (CNI) with a dual mechanism of action, acting as an immunosuppressant by inhibiting T cell activation and cytokine production and promoting podocyte stability in the kidney. The recommended starting dose of LUPKYNIS is three capsules twice daily without the need for serum drug monitoring. Dose modifications can be made based on Aurinia’s eGFR-based personalized dosing protocol. The boxed warning, warnings and precautions for LUPKYNIS are consistent with those for other CNI immunosuppressive treatments.
Aurinia Pharmaceuticals is a fully integrated biopharmaceutical company focused on providing therapies to treat targeted patient populations that are affected by serious diseases with high unmet medical need. In January 2021, the Company launched LUPKYNIS® (voclosporin), the first FDA-approved oral therapy for the treatment of adult patients with active lupus nephritis (LN). The company’s headquarters are in Victoria, British Columbia, its US trading center is in Rockville, Maryland. The Company focuses its development efforts on a global scale.
INDICATION AND IMPORTANT SAFETY INFORMATION
LUPKYNIS is indicated in combination with a background immunosuppressive regimen for the treatment of adult patients with active LN. Limitations of Use: The safety and effectiveness of LUPKYNIS in combination with cyclophosphamide have not been established. The use of LUPKYNIS is not recommended in this situation.
IMPORTANT SAFETY INFORMATION
BOXED WARNINGS: MALIGNANCES AND SERIOUS INFECTIONS
Increased risk of developing malignancies and serious infections with LUPKYNIS or other immunosuppressants which may lead to hospitalization or death.
LUPKYNIS is contraindicated in patients taking strong CYP3A4 inhibitors due to increased risk of acute and/or chronic nephrotoxicity, and in patients who have had a serious/severe hypersensitivity reaction to LUPKYNIS or its excipients.
WARNINGS AND PRECAUTIONS
Lymphoma and other malignancies: Immunosuppressants, including LUPKYNIS, increase the risk of developing lymphomas and other malignancies, especially of the skin. The risk appears to be related to increasing doses and the duration of immunosuppression rather than to the use of a specific agent.
Serious infections: Immunosuppressants, including LUPKYNIS, increase the risk of developing bacterial, viral, fungal, and protozoal infections (including opportunistic infections), which can have serious or even fatal outcomes.
Nephrotoxicity: LUPKYNIS, like other CNIs, can cause acute and/or chronic nephrotoxicity. The risk is increased when CNIs are given concomitantly with drugs associated with nephrotoxicity.
Hypertension: Hypertension is a common side effect of treatment with LUPKYNIS and may require antihypertensive treatment.
Neurotoxicity: LUPKYNIS, like other CNIs, can cause a range of neurotoxicities: serious ones include posterior reversible encephalopathy syndrome (PRES), delirium, seizures, and coma; others include tremors, paresthesias, headaches, and changes in mental status and/or motor and sensory functions.
Hyperkalemia: Hyperkalemia, which may be serious and require treatment, has been reported with ICNs, including LUPKYNIS. Concomitant use of agents associated with hyperkalemia may increase the risk of hyperkalemia.
QTc Interval Prolongation: LUPKYNIS prolongs the QTc interval in a dose-dependent manner when administered at a dose higher than the recommended therapeutic dose for lupus nephritis. Use of LUPKYNIS in combination with other drugs known to prolong the QTc interval may result in clinically significant prolongation of the QT interval.
Immunizations: Avoid the use of live attenuated vaccines during treatment with LUPKYNIS. Inactivated vaccines known to be safe for administration may not be sufficiently immunogenic during treatment with LUPKYNIS.
Pure red blood cell aplasia: Cases of pure red blood cell aplasia (PRCA) have been reported in patients treated with another CNI immunosuppressant. If PRCA is diagnosed, consider discontinuation of LUPKYNIS.
Drug-Drug Interactions: Avoid co-administration of LUPKYNIS with strong CYP3A4 inhibitors or with strong or moderate CYP3A4 inducers. Reduce LUPKYNIS dosage when co-administered with moderate CYP3A4 inhibitors. Reduce dosage of some P-gp substrates with narrow therapeutic windows when co-administered.
The most common adverse reactions (>3%) were decreased glomerular filtration rate, hypertension, diarrhea, headache, anemia, cough, urinary tract infection, upper abdominal pain, dyspepsia, alopecia, renal failure, abdominal pain, mouth ulcerations, fatigue, tremors. , acute kidney injury and decreased appetite.
Pregnancy/Nursing: May damage the unborn child. Not recommend breastfeeding.
Renal Impairment: Not recommended in patients with baseline eGFR ≤ 45 mL/min/1.73 m2 unless the benefit outweighs the risk. Severe renal impairment: Reduce the dose of LUPKYNIS.
Mild and moderate hepatic impairment: Reduce the dose of LUPKYNIS. Severe hepatic impairment: Avoid the use of LUPKYNIS.
Please see Prescribing Information including Boxed Warning and Medication Guide for LUPKYNIS.
Corporate Communications, Aurinia