Marketing Authorization Application Submitted to the EMA for Novel Lupus Nephritis Therapy

Aurinia Pharmaceuticals has just announced that Otsuka Pharmaceutical Europe Ltd. (OPEL), their licensing partner, has just filed a Marketing Authorization Application for an investigative therapy for lupus nephritis (LN) called voclosporin to the EMA.

The FDA has just approved this therapy for LN (January of 2021) when used in combination with an immunosuppressive regimen. It is approved for adult patients who have active disease. The treatment in the U.S. is available under the name LUPKYNIS.

Lupus Nephritis

Lupus nephritis is a condition that can arise as a complication of systemic lupus erythematosus (SLE). SLE is a chronic autoimmune condition. LN is a serious complication that can stem from SLE, effecting the kidneys.

Unfortunately, this condition is fairly common in individuals with SLE. One in every 3 patients with SLE will also develop LN.

When LN is not effectively treated it can cause irreversible, permanent damage to the tissue within the kidneys. This can ultimately lead to kidney failure.

Further, Asian SLE patients and African American SLE patients are 4x more likely to face LN and Hispanic SLE patients are 2 times as likely to face LN compared to white SLE patients. These patients also develop LN sooner than white patients and generally have poorer outcomes.

The Licensing Agreement

Back in December of 2020, Aurinia and OPEL entered a licensing agreement for voclosporin. The companies will collaborate on the development of the treatment and its commercialization for LN within the European Union, Russia, Iceland, Switzerland, the United Kingdom, Japan, Norway, Liechtenstein, Belarus, as well as the Ukraine.

After the marketing application is approved by the EMA, OPEL will be able to market the therapy in the EU, Liechtenstein, Iceland, and Norway.

You can read more about this therapy, LN, and the new marketing application for voclosporin here.

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