Aurinia Pharmaceuticals recently announced the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to voclosporin, a next-generation calcineurin inhibitor under development to treat patients with lupus nephritis (LN) and other autoimmune diseases.
LN is a kidney inflammation caused by systemic lupus erythematosus (SLE) in which patients may develop proteinuria, hematuria, and a decrease of renal function.
Without effective treatment, lupus nephritis can lead to permanent and irreversible tissue damage in the kidney, resulting in end-stage renal disease, thus making LN a serious and potentially life-threatening condition. LN is generally treated by the administration of immune-suppressants, with mycophenolate mofetil (MMF) and corticosteroids accounting for the current standard treatment.
The FDA’s Fast Track designation is a process designed to facilitate the development and expedite the review of drugs to treat serious conditions and fill an unmet medical need. The purpose of Fast Track is to get important new drugs to the patient earlier, offering companies the opportunity to have frequent meetings with the FDA to review the drug’s development protocol, including clinical trials design and the use of biomarkers to back up approval. Fast Track also allows companies to submit parts of the New Drug Application (NDA) for review as clinical data becomes available.
British Columbia, Canada-based Aurinia has recently completed enrollment in AURA (Aurinia Urine protein Reduction in Active Lupus with voclosporin, NCT02141672), a randomized, double-blind, placebo-controlled, Phase 2b clinical trial that is comparing the safety and efficacy of Voclosporin with a placebo in remission for 265 patients with active lupus nephritis. The trial is currently underway in more than 20 countries worldwide.
The primary analysis will assess complete remission at week 24 and secondary analysis at week 48, and includes biomarkers and markers of non-renal SLE. Aurinia is expecting to review the results of AURA with the FDA later this year for agreements on other 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,” Lawrence Mandt, Aurinia’s vice president of regulatory affairs and quality, said in a press release.