Aurinia Pharma Reaffirms LUPKYNIS Safety And Efficacy Following Retracted FDA Official's Post

(RTTNews) - Responding to a now retracted LinkedIn post referencing voclosporin by an FDA official, Aurinia Pharmaceuticals Inc. (AUPH) stated that it stands firmly behind the favorable benefit/risk profile of LUPKYNIS (voclosporin). The drug received full FDA approval in January 2021, supported by data from AURORA 1—a large, randomized 52-week clinical trial. In April 2024, the FDA further approved a supplementary new drug application for long-term use of LUPKYNIS, based on AURORA 2 results, which confirmed sustained efficacy over three years and a safety profile consistent with AURORA 1.

Earlier today, George Tidmarsh, director of the FDA's Center for Drug Evaluation and Research, reportedly said in a LinkedIn post that the company's voclosporin, which was approved by the FDA in 2021, has "significant toxicity" and has not been shown to have a positive impact on patients. CDER will be evaluating surrogate endpoints used for FDA approval.

AUPH closed Monday's regular trading at $11.06 down $2.08 or 15.83%. But in the After hours trading the stock gained $0.81 or 7.32%.