The U.S. Food & Drug Administration (FDA) Approves Updated LUPKYNIS® (voclosporin) Label to include Long-Term Data from the AURORA Clinical Program

Rhea-AI Summary

The FDA has approved an updated label for LUPKYNIS, a drug by Aurinia Pharmaceuticals (NASDAQ: AUPH), including long-term data from the AURORA Clinical Program, showing sustained complete renal response through three years. The label now indicates that monthly kidney function assessment is no longer required after the first year of treatment. The safety profile of LUPKYNIS remains unchanged and aligns with the AURORA clinical program's findings.

Positive

• Sustained complete renal response with LUPKYNIS over three years

• No longer requiring monthly kidney function assessment after the first year

• Updated label providing guidance for monitoring kidney function in patients

• Addition of lactation data on the transfer of LUPKYNIS to breast milk for informed decisions

Negative

• None.

• New data showing sustained complete renal response with LUPKYNIS through three years
• Monthly kidney function assessment no longer required after first year of treatment
• Safety profile remains unchanged and is aligned with the safety findings in the AURORA clinical program

ROCKVILLE, Md. & EDMONTON, Alberta--(BUSINESS WIRE)-- Aurinia Pharmaceuticals Inc. (NASDAQ: AUPH) (Aurinia or the Company) today announced that the FDA has approved a label update for LUPKYNIS. The updated label no longer includes language indicating that the safety and efficacy of LUPKYNIS has not been established beyond one year. The label now includes three-year data from the AURORA 2 double-blind, placebo-controlled extension study, which assessed the long-term safety and tolerability of LUPKYNIS in combination with mycophenolate mofetil (MMF) and low-dose glucocorticoids, compared with MMF and low-dose glucocorticoids alone, in adults with active lupus nephritis (LN) who completed the Phase 3 AURORA 1 clinical trial.

A post hoc analysis of data from the extension study now included in the label showed that, among the 179 patients receiving LUPKYNIS and 178 patients receiving placebo in AURORA 1, 20.1% (n=36) and 11.8% (n=21) achieved sustained complete renal response (SCRR), respectively. SCRR was defined as achieving renal response at month 12 of AURORA 1 and maintaining renal response at subsequent clinic visits through the end of the extension study at month 36. The label also notes that 21.8% (n = 39) of patients receiving LUPKYNIS, and 23% (n = 41) in the placebo arm, had missing data at the end of the first year or by the end of the two-year extension study, and therefore have an unknown status for sustained complete renal response.

The updated label also provides new guidance for monitoring kidney function in patients taking LUPKYNIS. The label indicates that physicians should assess eGFR every two weeks for the first month of treatment, every four weeks through the first year, and quarterly thereafter. The label had previously stated that eGFR should be assessed every four weeks for the duration of treatment. The updated LUPKYNIS label supports quarterly monitoring of eGFR after the first year of treatment, which is more consistent with current standard clinical care.

“Data from our AURORA 2 extension study included in the LUPKYNIS label showed a maintenance of sustained complete renal response with LUPKYNIS in combination with MMF and low-dose glucocorticoids, at every time point assessed through three years, relative to MMF and low-dose glucocorticoids alone. This notable outcome is aligned with treatment guidelines calling for use of LUPKYNIS for at least three years to reduce proteinuria. Additionally, guidance on monitoring kidney function quarterly after the first year of LUPKYNIS treatment reflects the reality of clinical practice. Overall, this label update provides physicians with important information to treat and manage their LN patients,” said Dr. Greg Keenan, Chief Medical Officer of Aurinia.

The safety profile of LUPKYNIS in the updated label remains unchanged and is aligned with the safety findings in the AURORA Clinical Program.

The updated label also provides additional lactation data on the transfer of LUPKYNIS to breast milk based on a twice daily dosing regimen. This information will be useful to lactating women and their health care providers who need to make informed decisions about breast feeding while taking LUPKYNIS.

About the AURORA Clinical Program

In AURORA 1 (referred to in label as Study 1), a 12-month, phase 3, double-blind, randomized-controlled pivotal study, the efficacy and safety of voclosporin was compared with a control group in achieving CRR in patients with LN. AURORA 1 demonstrated the clinical superiority of voclosporin with mycophenolate mofetil (MMF) and low-dose glucocorticoids compared to MMF and low-dose glucocorticoids alone. Significantly more patients in the voclosporin group achieved a CRR at 52 weeks of treatment and did so significantly faster than those in the control group. The safety profile in AURORA 1 was comparable between treatment groups, in line with previous studies; no new safety concerns were observed. Results from the completed Phase 3 randomized, double-blind, placebo-controlled, multicenter AURORA 1 study were published in The Lancet.

AURORA 2 (referred to in label as Study 1 extension), a Phase 3, double-blind, extension study assessed the long-term safety and tolerability of voclosporin, in addition to MMF and low-dose glucocorticoids, for the treatment of patients with active LN. Voclosporin was well tolerated with no new or worsening safety signals in the extension study. Clinical efficacy over three years of treatment was maintained, as observed by maintenance of urine protein creatinine ratio reductions, sustained complete renal response and preserved kidney function, suggesting a positive benefit-risk profile for voclosporin in LN patients. Full results of the extension study were published in Arthritis & Rheumatology, the official peer-reviewed journal of the American College of Rheumatology.

Patients who completed 12 months of treatment in the Phase 3 AURORA 1 study were eligible to enroll in the AURORA 2 extension study with the same randomized treatment of voclosporin or placebo, in combination with MMF (target dose of 2 g/day) and low-dose glucocorticoids (target dose of ≤2.5 mg/day), for an additional 24 months.

A total of 216 LN patients continued into the extension study, with 116 patients in the voclosporin group and 100 patients in the control group; 90 and 78 patients, respectively, received 36 months of total treatment at the completion of the study. Study drug dose changes decreased over time.

About LUPKYNIS^®

LUPKYNIS^® (voclosporin) is the first U.S. Food and Drug Administration and European Commission approved oral medicine for the treatment of adult patients with active lupus nephritis (LN). LUPKYNIS^® is a second generation calcineurin inhibitor (CNI) with a dual mechanism of action, acting as an immunosuppressant through inhibition of T-cell activation and cytokine production and promoting podocyte stability in the kidney. The AURORA Clinical Program, comprised of the AURORA 1 pivotal trial and AURORA 2 extension trial, demonstrated the importance of LUPKYNIS^® plus standard of care to preserve kidney health in patients with active LN without reliance on chronic high-dose glucocorticoids. It is the only clinical program to include three years of LN treatment and follow-up with mycophenolate mofetil (MMF) and steroids.

About Lupus Nephritis

Lupus Nephritis (LN) is a serious manifestation of systemic lupus erythematosus (SLE), a chronic and complex autoimmune disease. LN affects approximately 120,000 people in the U.S. and disproportionately affects women and people of color. People living with LN have high unmet needs and often face significant barriers to optimal care. If poorly controlled, LN can lead to permanent and irreversible tissue damage within the kidney. Medical guidelines recommend that all SLE patients receive routine LN screenings at every visit. Guidelines also note that delaying LN diagnosis has profound prognostic repercussions. Yet, research shows that approximately 50% of SLE patients are not screened for LN and 77% of people with LN go untreated. Aurinia is committed to improving health outcomes for people living with LN by educating patients and providers on the critical need for routine screening and transformative therapies that can help improve health outcomes.

About Aurinia

Aurinia Pharmaceuticals is a fully integrated biopharmaceutical company focused on delivering therapies to people living with autoimmune diseases with high unmet medical needs. In January 2021, the Company introduced LUPKYNIS® (voclosporin), the first FDA-approved oral therapy dedicated to the treatment of adult patients with active lupus nephritis. The Company’s head office is in Edmonton, Alberta, its U.S. commercial office is in Rockville, Maryland. The Company focuses its development efforts globally.

INDICATION AND IMPORTANT SAFETY INFORMATION

INDICATION

LUPKYNIS^® is indicated in combination with a background immunosuppressive therapy regimen for the treatment of adult patients with active LN. Limitations of Use: Safety and efficacy of LUPKYNIS have not been established in combination with cyclophosphamide. Use of LUPKYNIS is not recommended in this situation.

IMPORTANT SAFETY INFORMATION

BOXED WARNINGS: MALIGNANCIES AND SERIOUS INFECTIONS

Increased risk for developing malignancies and serious infections with LUPKYNIS or other immunosuppressants that may lead to hospitalization or death.

CONTRAINDICATIONS: LUPKYNIS is contraindicated in patients taking strong CYP3A4 inhibitors because of the 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, particularly of the skin. The risk appears to be related to increasing doses and duration of immunosuppression rather than to the use of any specific agent.

Serious Infections: Immunosuppressants, including LUPKYNIS, increase the risk of developing bacterial, viral, fungal, and protozoal infections, including opportunistic infections. This may lead to serious, even fatal, outcomes.

Nephrotoxicity: LUPKYNIS, like other calcineurin inhibitors (CNIs), may cause acute and/or chronic nephrotoxicity. The risk is increased if administered with drugs associated with nephrotoxicity. Monitor eGFR regularly.

Hypertension: Hypertension is a common adverse reaction of LUPKYNIS therapy that may require antihypertensive therapy. Monitor blood pressure regularly.

Neurotoxicity: LUPKYNIS, like other CNIs, may cause neurotoxicities that if severe can include posterior reversible encephalopathy syndrome, delirium, seizure, and coma; others include tremor, paresthesia, headache, and changes in mental status and/or motor and sensory functions. Monitor for neurologic symptoms.

Hyperkalemia: Hyperkalemia, which may be serious and require treatment, has been reported. Concomitant use of agents associated with hyperkalemia may increase the risk for hyperkalemia. Monitor serum potassium periodically.

QTc Prolongation: LUPKYNIS prolongs the QTc interval in a dose-dependent manner when dosed higher than the recommended lupus nephritis therapeutic dose. The use of LUPKYNIS in combination with other drugs that are known to prolong QTc may result in clinically significant QT prolongation.

Immunizations: Avoid the use of live attenuated vaccines during treatment with LUPKYNIS. Inactivated vaccines noted to be safe for administration may not be sufficiently immunogenic during treatment with LUPKYNIS.

Pure Red Cell Aplasia: Cases of pure red cell aplasia have been reported in patients treated with another CNI. If PRCA is diagnosed, consider discontinuation of LUPKYNIS.

ADVERSE REACTIONS

The most common adverse reactions (>3%) were glomerular filtration rate decreased, hypertension, diarrhea, headache, anemia, cough, urinary tract infection, abdominal pain upper, dyspepsia, alopecia, renal impairment, abdominal pain.

Drug-Drug Interactions: Avoid co-administration of LUPKYNIS and strong CYP3A4 inhibitors or with strong or moderate CYP3A4 inducers. Co-administration of LUPKYNIS with strong CYP3A4 inhibitors is contraindicated. Reduce LUPKYNIS dosage when co-administered with moderate CYP3A4 inhibitors. Avoid use of LUPKYNIS with strong or moderate CYP3A4 inducers.

SPECIFIC POPULATIONS

Pregnancy: Avoid use of LUPKYNIS.

Lactation: Consider the benefits and risks of LUPKYNIS and possible risks to the fetus when prescribing LUPKYNIS to a lactating woman.

Renal Impairment: LUPKYNIS is not recommended in patients with baseline eGFR ≤45 mL/min/1.73 m2 unless benefit exceeds risk. If used in this population, reduce LUPKYNIS dose.

Hepatic Impairment: For mild or moderate hepatic impairment, reduce LUPKYNIS dose. Avoid use with severe hepatic impairment.

Please see Prescribing Information, including Boxed Warning, and Medication Guide for LUPKYNIS.

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Media & Investor Inquiries:

Andrea Christopher,

Corporate Communications & Investor Relations,

achristopher@auriniapharma.com

ir@auriniapharma.com

Source: Aurinia Pharmaceuticals Inc.