Lupkynis approved in Japan to treat lupus nephritis
Developer says country has a high rate of the kidney condition
Lupkynis (voclosporin) is now approved in Japan to treat lupus nephritis, a complication of lupus marked by kidney damage and inflammation.
The Japanese Ministry of Health, Labour, and Welfare approved the treatment’s use in combination with the immunosuppressant mycophenolate mofetil.
Otsuka Pharmaceutical filed a new drug application with Japanese authorities in November 2023 seeking the therapy’s approval. Otsuka holds development and marketing rights to Lupkynis in Japan and other countries as part of a license agreement with developer Aurinia Pharmaceuticals. Aurinia will supply the oral therapy to Otsuka in support of the marketing launch in Japan.
The approval makes Aurinia eligible to receive a $10 million payment, in addition to “low double-digit royalties on net sales” once the product is launched, according to a company press release.
Lupkynis has approval to treat active lupus nephritis in the U.K., European Union, Switzerland, as well as the U.S.
Lupus nephritis rate high in Japan
“We are thrilled to achieve this milestone that will provide access to Lupkynis in Japan, where there is a high rate of lupus nephritis among Japanese lupus patients,” said Peter Greenleaf, Aurinia’s president and CEO. “Our successful strategic partnership with Otsuka has allowed us to bring LUPKYNIS to [lupus nephritis] patients across Europe and now Japan, addressing a significant unmet need.”
Lupus nephritis is a potentially serious complication of lupus that arises when the immune system erroneously launches an attack against the kidneys, causing damage and inflammation. If left untreated, the damage caused to the kidneys can lead to kidney failure.
Lupkynis is designed to lessen the inflammation that drives lupus nephritis, and to support the health and function of kidney cells. It works by blocking the activity of a specific protein, called calcineurin, which is known for its ability to activate T-cells, a type of immune cells involved in inflammation.
Its approval in Japan was based on the AURORA Clinical Program, which included the Phase 3 AURORA clinical trial (NCT03021499) and its extension study, AURORA 2 (NCT03597464).
Findings from these studies indicated that Lupkynis was better than a placebo at stabilizing kidney function after one year, when given alongside mycophenolate mofetil and low-dose steroids.
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