Otsuka seeks approval in Japan of Lupkynis for lupus nephritis
Oral therapy was 1st to be approved for condition in US, UK, and EU
The new drug application filed by Otsuka will be reviewed and decided upon by the Japanese Ministry of Health, Labour, and Welfare. No estimate was provided by the company as to when a decision may be made.
Otsuka signed a license agreement with Aurinia Pharmaceuticals, Lupkynis’ developer, in December 2020 to obtain marketing rights for the oral therapy in Japan and Europe. If approved in Japan, Aurinia could get $10 million along with low double-digit royalties on net sales after its launch.
“Lupus nephritis is a serious, complex condition associated with SLE, that can benefit from advanced therapies that focus toward the treatment goal of kidney preservation,” Peter Greenleaf, Aurinia’s president and CEO, said in a company press release.
“We look forward to continuing to work with Otsuka to expand availability to [Lupkynis] and provide patients and physicians access to this new therapy that addresses a significant unmet need in lupus nephritis,” Greenleaf added.
Lupkynis designed for use as part of immunosuppressive treatment plan
Lupus nephritis occurs when immune cells go haywire and mistakenly attack the kidneys, resulting in long-lasting inflammation. Inflammation in the kidney’s filters is known as glomerulonephritis.
Left untreated, lupus nephritis can damage the kidneys and cause them to stop working properly.
“The challenge is to achieve rapid remission of glomerulonephritis with reduction in [excess protein in urine], while avoiding long-term use of high doses of steroid medication,” Otsuka stated in a separate press release.
Lupkynis is the first oral treatment approved in the U.S. and the U.K., as well as in the European Union, for adults with active lupus nephritis. It is meant to be used as part of a background immunosuppressive treatment plan that may include mycophenolate mofetil and low-dose corticosteroids.
The medication works by blocking calcineurin, a protein that activates T-cells, a type of immune cell involved in inflammation. By calming the immune response, Lupkynis is expected to ease inflammation and other symptoms of lupus nephritis.
Besides working as an immunosuppressive agent, Lupkynis also protects the kidneys from further damage by preserving podocytes, a type of specialized cells in the kidneys that wrap around blood vessels to help filter waste and fluid from blood and form urine.
The therapy’s approvals elsewhere were mainly based on results from the Phase 3 AURORA clinical trial (NCT03021499), which involved 358 adults with active lupus nephritis, and its extension study, called AURORA 2 (NCT03597464).
Data showed that Lupkynis outperformed a placebo at stabilizing kidney function after one year of treatment. Up to three years of treatment continued to be safe and to protect patients’ kidney function.