New Drug Application Submitted to the FDA for Lupus Nephritis

Lupus Nephritis

Systemic lupus erythematosus (SLE) is a rare, chronic condition which affects a wide array of tissues in the body. A condition which signifies severe SLE progression is lupus nephritis (LN).

LN is characterized by kidney inflammation, and it can be debilitating for patients, severely reducing their quality of life. The damage it has on the kidneys can be permanent, making it life-threatening. A reduction in renal function can be shown by reduced eGFR as well as an increase in serum creatinine.

Unfortunately, there has yet to be a treatment approved by the FDA for this condition.

Aurinia Pharmaceuticals recently submitted a New Drug Application to the FDA for an investigative therapy for this disease. It is called voclosporin.

Voclosporin

Voclosporin is an investigative calcineurin inhibitor or CNI. It works as an immunosuppressant. It inhibits calcineurin and blocks the expression of IL-2 as well as T-cell mediated immune responses. Further, it stabilizes the podocyte’s in the kidney.

Researchers now have data for 2,600 Lupus Nephritis patients. These come from the AURA trial as well as the AURORA trial. Both showed strong support for this new therapy. Due to these positive results, the team was able to offer their submission ahead of schedule.

A component of the recent submission is the request for a priority review for voclosporin, which would mean an FDA decision within 8 months instead of 12.

The company expects approval by early in 2021. Following approval, they expect extension to Europe as well as Japan. They also hope for a pediatric extension.

You can read more about this new investigative therapy here.


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