FDA updates Lupkynis label to include long-term efficacy data
Medicine is approved to treat lupus nephritis
The U.S. Food and Drug Administration (FDA) has updated the prescribing label for Lupkynis (voclosporin), which is approved to treat a severe manifestation of lupus called lupus nephritis, to include data that shows it continues to safely preserve kidney function for up to three years.
The data came from AURORA 2 (NCT03597464), a two-year extension to the one-year Phase 3 AURORA 1 trial (NCT03021499) that looked at how safe Lupkynis is and how well it works in adults with lupus nephritis when given on top of mycophenolate mofetil (MMF) and low-dose corticosteroids.
After three years, more patients on Lupkynis achieved a sustained complete renal response — meaning they had a positive response to treatment after a year in AURORA 1 and maintained it for the next two years in AURORA 2 — compared with those on placebo.
The updated label includes revised guidelines for monitoring the estimated glomerular filtration rate (eGFR), a measure of kidney function, in patients receiving Lupkynis. Monitoring is now recommended every two weeks for the first month, every four weeks through the first year, and quarterly thereafter, instead of every four weeks for the entire duration of treatment.
The label also includes data that shows Lupkynis can pass into breast milk, which may help nursing women and healthcare providers better decide if it should be used during breastfeeding.
After a single 23.7 mg dose, an average 0.00472 mg of Lupkynis’ active ingredient was found in the breast milk of healthy mothers, which corresponds to an estimated 1.4% of the maternal weight-adjusted dose ingested by the nursing infant.
“This label update provides physicians with important information to treat and manage their [lupus nephritis] patients,” Greg Keenan, MD, chief medical officer of Aurinia Pharmaceuticals, which markets Lupkynis, said in a company press release.
Effect of Lupkynis on lupus nephritis
In lupus nephritis, the immune system mistakenly launches an inflammatory attack against the kidneys. Left untreated, this can result in their permanent damage and cause them to fail, putting patients at risk for long-term complications.
Lupkynis both reduces inflammation and stabilizes kidney cells. It’s approved in the U.S., the European Union, the U.K., and Switzerland as an oral medication to be used alongside background immunosuppressive treatment for adults with active lupus nephritis.
In AURORA 1, patients assigned to receive a twice-daily dose of Lupkynis were more than 2.5 times more likely than those on a placebo to achieve a complete renal response, which is a measure of treatment response that takes into account kidney function, proteinuria, or excess protein in urine and a sign of kidney damage, and the need for rescue medication or a higher dose of corticosteroids.
Of the 357 patients in AURORA 1, 216 rolled over into AURORA 2 and continued to take either Lupkynis or a placebo alongside MMF and low-dose corticosteroids for two more years.
There, Lupkynis continued to outperform the placebo. Of the initial 179 patients assigned to the Lupkynis arm, 36 (20.1%) achieved a sustained complete renal response, that is, they showed a complete renal response at each study visit over three years. In the placebo group, this figure was 11.8%.
“Data from our AURORA 2 extension study included in the Lupkynis label showed a maintenance of sustained complete renal response with Lupkynis in combination with MMF and low-dose [corticosteroids], at every time point assessed through three years, relative to MMF and low-dose [corticosteroids] alone,” Keenan said. “This notable outcome is aligned with treatment guidelines calling for use of Lupkynis for at least three years to reduce proteinuria.”
Data were missing for 80 patients (39 on Lupkynis, 41 on placebo), either at the end of the first year or by the end of the extension, and a sustained complete renal response couldn’t be determined for them.
The safety profile of Lupkynis in the label remains unchanged.
