Decision by MHRA comes less than 3 months after EU approval
by Marisa Wexler, MS | December 5, 2022
Lupkynis (voclosporin) has been approved in Great Britain as a treatment for adults with active lupus nephritis by the U.K.’s Medicines and Healthcare products Regulatory Agency (MHRA), Aurinia Pharmaceuticals, the therapy’s developer, announced.
The MHRA’s approval came just a few months after the European Commission approved Lupkynis for the same indication in all EU member states. The therapy was approved in the U.S. in 2021.
According to Aurinia, Lupkynis is the first oral medicine approved in the U.S. and Europe to treat active lupus nephritis, which is a serious complication of systemic lupus erythematosus (SLE), characterized by kidney inflammation.
“The MHRA authorization of Lupkynis for individuals with lupus nephritis in Great Britain, on the heels of the marketing authorization in the EU, further expands the availability of Lupkynis as a treatment option for people with lupus nephritis,” said Peter Greenleaf, president and CEO of Aurinia, in a press release.
Aurinia is working in collaboration with Otsuka Pharmaceutical to commercialize Lupkynis in the EU, the U.K., and other regions under a 2020 agreement established between the companies.
“Otsuka has been a valued partner in these efforts, and we are pleased to work with them to reach new patients,” Greenleaf said.
Lupkynis is designed to simultaneously reduce the inflammation that drives lupus nephritis, and to support the health and functioning of kidney cells. It works by blocking the activity of a protein called calcineurin.
The recommended starting dose is three 7.9 mg capsules taken twice daily. This dose can be adjusted based on measures of kidney function through a proprietary protocol developed by Aurinia.
Lupkynis approvals in the EU and Britain were supported by data from the Phase 3 AURORA trial (NCT03021499), which tested the therapy against a placebo in 358 adults with active lupus nephritis for one year. Those who completed the initial study could enroll in an extension study called AURORA2 (NCT03597464), that continued comparing Lupkynis against placebo for another two years.
Results from AURORA showed that patients on Lupkynis were significantly more likely to have stable kidney function than those on placebo.
Participants in both groups were also given standard anti-inflammatory medications (mycophenolate mofetil and low-dose corticosteroids) during the study, and safety outcomes were comparable in both groups.
Common side effects associated with Lupkynis include changes in kidney function, acute kidney injury, high blood pressure, diarrhea, headache, anemia, cough, urinary tract infection, abdominal pain, indigestion, hair loss, mouth ulcers, fatigue, tremor, and decreased appetite. The therapy also may increase the risk of serious infections and cancer. According to Aurinia, these side effects “are consistent with those of other [immunosuppressive] treatments.”
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