FDA approves updated label for Lupkynis with long-term data, new monitoring guidelines
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Key takeaways:
- The updated label includes 3-year data in which 20.1% of treated patients achieved sustained complete renal response.
- New guidance suggests quarterly kidney function checks after the first year of treatment.
The FDA has approved an updated label for Lupkynis, an oral treatment for active lupus nephritis, that includes long-term safety and tolerability data, and eases the requirement for monthly kidney function assessments.
The new label for Lupkynis (voclosporin, Aurinia Pharmaceuticals) now accounts for a post-hoc analysis of 3-year data from a double-blind, placebo-controlled extension study, AURORA 2, according to a press release from Aurinia.
The study compared voclosporin vs. placebo, both in combination with mycophenolate motefil and low-dose glucocorticoids. At 36 months, 20.1% of patients treated with voclosporin in the original 12-month AURORA 1 trial achieved sustained complete renal response vs. 11.8% of those who received placebo.
“This notable outcome is aligned with treatment guidelines calling for use of Lupkynis for at least 3 years to reduce proteinuria,” Gregory Keenan, MD, chief medical officer at Aurinia, said in the release.
The new label also removes former guidance that glomerular filtration rate (eGFR) should be assessed by a physician every 4 weeks. The updated label now suggests that physicians should assess eGFR every 2 weeks for the first month of treatment, then every 4 weeks through the first year, and quarterly thereafter.
“Guidance on monitoring kidney function quarterly after the first year of Lupkynis treatment reflects the reality of clinical practice,” Keenan said. “Overall, this label update provides physicians with important information to treat and manage their [lupus nephritis] patients.”
The safety profile of Lupkynis remains unchanged, according to the company.
The label additionally now notes there were missing data for 21.8% of patients treated with voclosporin and 23% in the placebo arm who “therefore have an unknown status for sustained complete renal response,” according to the release.
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