FDA Official Criticizes Aurinia’s Lupus Drug Toxicity amid Approval Review

Aurinia Pharmaceuticals experienced significant stock volatility following criticism from George Tidmarsh, director of the FDA's Center for Drug Evaluation and Research, regarding its flagship lupus nephritis drug, voclosporin (Lupkynis). Tidmarsh highlighted concerns about the drug's "significant toxicity" and the lack of demonstrated direct clinical benefits, pointing to the reliance on surrogate endpoints for its 2021 FDA approval. This criticism led to a sharp stock decline of up to 21%, although Aurinia later defended the drug's approval process by emphasizing robust Phase 3 trial data and FDA endorsement for long-term use, resulting in a partial recovery in share price. The FDA is reviewing its use of surrogate endpoints to balance faster drug approvals with the need for confirmatory clinical trials evidencing actual patient benefits. Despite these challenges, Aurinia maintains strong financial health, with solid profitability and a promising pipeline targeting autoimmune diseases. The debate underscores ongoing tensions between regulatory standards and the urgency to bring new therapies to patients with unmet medical needs.