Pharma company Aurinia falls after FDA official uses LinkedIn to call out lupus drug
Lupkynis, which was approved in 2021, is Aurinia’s primary source of revenue.
Aurinia Pharmaceuticals dropped on Monday after a Food and Drug Administration official criticized a method of evaluating drugs that was used to approve the company’s flagship lupus medication.
George Tidmarsh, who has led the FDA’s drug evaluation arm since July, said on LinkedIn that voclosporin, which is made by Aurinia under the brand name Lupkynis, has “significant toxicity” and has not been proven to benefit patients.
Specifically, he criticized the use of surrogate end points, which are indirect measures of patients’ health after taking a treatment that results in speedier trials. Tidmarsh said the FDA will be evaluating how it uses that kind of data for drug approval. Tidmarsh later deleted that post and in a subsequent post clarified that those were his personal views and not that of the FDA.
Tidmarsh’s complete, since deleted LinkedIn post read:
“CDER will be evaluating surrogate endpoints used for FDA approval. While there is no doubt that the use of such endpoints has benefited patients by bringing valuable treatments to patients sooner, there have been notable failures in confirmatory trials, such as those for exon skipping therapies in DMD. And for some diseases such as lupus nephritis, companies have not run trials to demonstrate a benefit on hard clinical endpoints like progression to end stage renal disease. So we have approved drugs with significant toxicity like voclosporin that has not been shown to provide a direct clinical benefit for patients. We will be taking a close look at the use of surrogate endpoints to see where we can further accelerate promising drugs faster while requiring companies to perform the trials necessary to confirm actual clinical benefit.”
Lupkynis, which was approved in 2021, is Aurinia’s primary source of revenue. The company reported $235.1 million in sales last year, and analysts polled by FactSet have penciled in $270.5 million for 2025.
Aurinia fell as much as 21% after Tidmarsh’s post, and it ended the day down 16%.
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