FDA Drug Approvals, Nephrology and Urology — 2021 Midyear Review

August 20, 2021

Lupkynis (voclosporin)

Voclosporin is an oral calcineurin inhibitor indicated in combination with a background immunosuppressive regimen for treatment of active lupus nephritis in adults.

The AURA-LV phase 3 trial randomized patients to placebo or an induction regimen that combined voclosporin with mycophenolate mofetil and low-dose oral corticosteroids. At 24 weeks, 32.6% of the low-dose voclosporin group achieved complete renal response (CRR) and 27.3% in the high-dose voclosporin group, compared with 19.3% in the placebo group. CRR rate in the low-dose and high-dose voclosporin groups was also higher than with placebo at 48 weeks. Kidney Int. Jan;95(1):219-231

The AURORA phase 3 trial compared the efficacy and safety of voclosporin (23.7 mg twice daily) with placebo in combination with mycophenolate and low-dose oral corticosteroids. At 1 year, the renal response rate was higher in the voclosporin group compared with placebo (40.8% vs 22.5%; odds ratio, 2.65; P <.001). In addition, the median time to the achievement of a urine protein-to-creatinine ratio below 0.5 mg/mg showed significant clinical improvement with voclosporin compared with placebo (169 vs 372 days; P <.001). Lancet . 2021 May 29;397(10289):2070-2080

Other nephrology and urology approvals

Farxiga (dapagliflozin) - Indication approved to reduce risk of sustained estimated glomerular filtration rate decline, end-stage kidney disease, cardiovascular death, and hospitalization for heart failure in adults with chronic kidney disease who are at risk of progression.

Myrbetriq (mirabegron) - FDA approval gained for neurogenic detrusor overactivity in children aged 3 years and older.

Botox (onabotulinumtoxinA) - New indication approved for neurogenic detrusor overactivity in children aged 5 years and older who have an inadequate response to or are intolerant of anticholinergic medications.


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