FDAnews
www.fdanews.com/articles/175642-aurinia-gains-fast-track-status-for-lupus-treatment

Aurinia Gains Fast Track Status for Lupus Treatment

March 8, 2016

Aurinia Pharmaceuticals has received FDA fast track designation for its calcineurin inhibitor — voclosporin — for the treatment of lupus nephritis.

Aurinia recently completed patient enrollment for an ongoing Phase 2b trial, which is comparing the efficacy of two doses of voclosporin in combination to mycophenolate mofetil versus MMF alone in patients with active lupus nephritis.

The company expects to review the trial data with the FDA later this year.