January 22, 2021

The U.S. FDA has approved Lupkynis™ (voclosporin), manufactured by Aurinia Pharmaceuticals, for use in combination with a background immunosuppressive therapy regimen to treat adults who have active lupus nephritis (LN). It is the first oral therapy to receive FDA approval to treat LN.

LN is a complication of systemic lupus erythematosus (lupus), an autoimmune disease that affects approximately a half million individuals in the United States. Lupus causes the production of immune proteins called autoantibodies that mistakenly attack healthy tissues in the body. LN occurs when these autoantibodies attack the kidneys, which can cause blood and protein in the urine, kidney inflammation, poor renal function, and renal failure.

In clinical studies, Lupkynis plus standard of care (SoC) was more than twice as effective at achieving a complete renal response than SoC alone. Patients on Lupkynis also attained a 50% reduction in urine protein/creatinine ratio (a measure of renal health) twice as quickly as patients receiving only SoC. A higher portion of Lupkynis-treated patients achieved complete renal response at 24 weeks of treatment compared to patients receiving SoC alone.

The recommended starting dose is 23.7mg orally, twice daily, taken by mouth at least eight hours apart and as close to 12 hours apart as possible, on an empty stomach. Patients should not consume grapefruit or grapefruit juice while on Lupkynis, as it can interfere with how the medication works. Lupkynis dosing is adjusted over time based on the patient’s eGFR (a measure of renal health), which should be assessed every two weeks for the first month of treatment with Lupkynis and every four weeks thereafter. In addition, the patient’s blood pressure should be monitored every two weeks for the first month and as clinically indicated thereafter.

Lupkynis is to be used in conjunction with mycophenolate mofetil (MMF) and corticosteroids. Prescribers should assess the risks and benefits of using Lupkynis beyond one year based on the patient’s treatment response and risk of worsening nephrotoxicity. If the patient has not experienced clinical benefit by 24 weeks of treatment, prescribers should consider discontinuing Lupkynis. A black box warning cautions that the use of immunosuppressants like Lupkynis is associated with an increased risk of serious infection and/or malignancies that may lead to hospitalization or death.

The product has been launched at a wholesale acquisition cost (WAC) of $3,950 per 60 capsules.

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