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.

Comments

3090D553-9492-4563-8681-AD288FA52ACE
Comments on Medscape are moderated and should be professional in tone and on topic. You must declare any conflicts of interest related to your comments and responses. Please see our Commenting Guide for further information. We reserve the right to remove posts at our sole discretion.
Post as:

processing....