Aurinia Pharmaceuticals on Monday pushed back on criticism of its lupus drug Lupkynis (voclosporin) by a top FDA official who had raised questions about the medicine’s clinical benefit in a LinkedIn post that has since been deleted.
Shares of Aurinia tumbled 16% to $11.06, marking their worst day since February 2024, before recovering 4% in after-hours trading to $11.51.
In a statement, Aurinia reiterated its positive outlook for Lupkynis, stating that it has an established benefit–risk profile. Aurinia highlighted that the drug was granted full FDA approval in January 2021 following the AURORA 1 study, and received additional approval in April 2024 based on data from the AURORA 2 study, which demonstrated its efficacy and safety over a three-year period.
The selloff followed a post by George Tidmarsh, director of the FDA’s drug center, who said Lupkynis “has not been shown to provide a direct clinical benefit for patients.” His comments were part of a broader discussion about the agency’s use of surrogate endpoints, which are biological measures used to accelerate drug approvals, that he said had led to both “notable successes and failures.”
The post drew widespread attention not only for its criticism of a specific drug and company, something regulators almost never do publicly, but also for its choice of platform.
Soon after media reports surfaced, Tidmarsh deleted the post and clarified that his comments were “personal views” that “do not reflect those of the FDA or HHS,” adding that all official communications would continue to be made through formal agency channels.
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