European Commission OKs Lupkynis for Active Lupus Nephritis
The oral therapy was approved in the US in 2021
The European Commission has approved Lupkynis (voclosporin) to treat active lupus nephritis, a serious complication of systemic lupus erythematosus (SLE) that is characterized by kidney inflammation.
The approval is valid in all European Union (EU) member states, as well as Iceland, Liechtenstein, Norway, and Northern Ireland. Lupkynis received a similar approval in the U.S. in early 2021, and applications for the therapy in Great Britain and Switzerland are currently under review.
Approval of the oral treatment for lupus nephritis ” … provides adults across Europe living with this potentially life-threatening disease a new treatment option,” Peter Greenleaf, president and CEO of Aurinia Pharmaceuticals, Lupkynis’ developer, said in a press release.
The therapy is commercialized in the EU and other markets in collaboration with Otsuka Pharmaceutical under an agreement established in 2020 between the two companies.
“People with lupus nephritis and their physicians have long been challenged by the lack of treatments available. In partnership with Otsuka, we’re excited to reach patients across Europe with a meaningful therapy that can help enable positive long-term kidney outcomes,” Greenleaf said.
Lupkynis is a modified calcineurin inhibitor that is designed to address lupus nephritis through two complementary biological mechanisms: reducing the inflammatory activity of immune cells that drive the disorder, and simultaneously promoting the stability of cells in the kidneys. The recommended dose for the therapy is three 7.9 mg capsules taken twice daily, though dose modifications may be made based on measures of kidney function.
Lupkynis’ approval was supported by data from a Phase 3 trial called AURORA (NCT03021499). The study enrolled 358 adults ages 18–75 with active lupus nephritis.
Participants were assigned randomly to take Lupkynis or a placebo for about one year. Participants in both groups also received treatment with standard anti-inflammatory medications (mycophenolate mofetil and low-dose corticosteroids).
Those who completed AURORA had the option to enroll in an extension study called AURORA2 (NCT03597464), which continued comparing the effects of Lupkynis to placebo for another two years.
Results showed that participants given Lupkynis were significantly more likely to experience stable kidney function than those given standard care, while safety outcomes in both groups were comparable.