Aurinia Addresses Retracted FDA LinkedIn Post—LUPKYNIS® Maintains Favorable Long-Term Profile Backed by AURORA Studies
LUPKYNIS® Backed by Multiple FDA Approvals and Three Years of Clinical Data
Aurinia Pharmaceuticals (NASDAQ: AUPH) moved swiftly to address concerns after a now-retracted LinkedIn post from an FDA official referenced voclosporin, the company’s leading drug for lupus nephritis. With questions briefly raised by the online statement, Aurinia reiterated its confidence in LUPKYNIS®, emphasizing that both the FDA’s initial full approval in 2021 and the more recent supplemental approval in April 2024 are grounded in robust clinical evidence.
AURORA 1 and 2 Studies Validate Efficacy and Safety Over Time
The FDA’s decisions stem from data across two key clinical studies. The pivotal AURORA 1 trial, a randomized, 52-week study, was instrumental in securing initial FDA approval. More recently, the long-term AURORA 2 extension demonstrated sustained efficacy for LUPKYNIS® over three years—crucially, safety findings from AURORA 2 remained consistent with those from the earlier trial, underlining a favorable risk/benefit profile for the therapy.
| Study | Duration | Findings | FDA Action |
|---|---|---|---|
| AURORA 1 | 52 weeks | Pivotal efficacy and safety in active lupus nephritis | Full approval (Jan 2021) |
| AURORA 2 | 3 years | Sustained efficacy, safety consistent with AURORA 1 | Supplemental approval (Apr 2024) |
Product Confidence Reinforced Amid Social Media Uncertainty
The episode underscores the speed at which social media statements can stir uncertainty in today’s market, even when retracted swiftly. By responding with transparency and reiterating long-term clinical outcomes, Aurinia has provided clarity for investors, patients, and healthcare providers alike.
Aurinia’s Broader Focus Remains on Autoimmune Innovation
LUPKYNIS® remains the first and only FDA-approved oral therapy for adult patients with active lupus nephritis—a disease area with significant unmet needs. Beyond LUPKYNIS®, Aurinia’s pipeline includes aritinercept (AUR200), a dual BAFF/APRIL inhibitor targeting further autoimmune indications.
Key Takeaway: Clinical Foundations Remain Firm Despite External Noise
The events surrounding the retracted LinkedIn post are a reminder that investor sentiment can be quickly swayed by unverified social media activity. However, the long-term efficacy and safety data underpinning LUPKYNIS®, and its ongoing regulatory backing, should remain the core focus for stakeholders tracking Aurinia’s outlook. Investors and patients may want to monitor any additional communications from both the company and regulators, especially as new pipeline developments progress.
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