The Fast Track program was created by the FDA to facilitate the development and expedite the review of new drugs that are intended to treat serious or life-threatening conditions and that demonstrate the potential to address significant unmet medical needs. Compounds that receive this FDA designation benefit from more frequent meetings and communications with the FDA to review the drug’s development plan including the design of clinical trials and the use of biomarkers to support approval. Additionally, Fast Track designation allows the company to submit parts of the New Drug Application (NDA) on a rolling basis for review as data becomes available.
Aurinia Pharmaceuticals’ 265 patient phase IIb trial, called AURA (Aurinia Urine protein Reduction in Active Lupus with voclosporin) has recently completed enrollment and is currently underway in over 20 countries worldwide. It is a randomized, controlled, double-blind study comparing the efficacy of two doses of voclosporin plus mycophenolate mofetil (MMF) vs. MMF alone in patients with active LN. There will be a primary analysis to determine complete remission at week 24 and various secondary analyses at week 48 which include biomarkers and markers of non-renal SLE. The company expects to analyse and review the AURA data with the FDA later in 2016 in order to reach agreement on further clinical development requirements.
“It is encouraging that Fast Track designation has been granted for voclosporin and we look forward to working closely with FDA as we complete the AURA trial. This designation demonstrates the substantial unmet medical need for patients with LN and potentially helps move a promising therapy through the FDA more rapidly,” said Lawrence Mandt, Aurinia’s vice president of Regulatory Affairs & Quality.