Shares of Aurinia Pharmaceuticals (NASDAQ:AUPH) are up by 10.4% as of 11:15 a.m. EDT on Wednesday, after the company announced that the U.S. Food and Drug Administration (FDA) accepted the filing of a New Drug Application (NDA) for Voclosporin.
Voclosporin is a potential treatment for Lupus Nephritis, an inflammation of the kidneys that can lead to kidney failure. Lupus Nephritis is caused by systemic lupus erythematosus (SLE), which is an autoimmune disorder. Aurinia initially submitted its NDA for Voclosporin in late May. The FDA granted Voclosporin priority review, which reduces the process to six months, as opposed to the standard of 10 months. The health-industry regulator has assigned a target-action date of Jan. 22, 2021.
Peter Greenleaf, CEO of Aurinia, said:
People living with [Lupus Nephritis] are in need of an advanced therapy that quickly drives the disease into remission and mediates kidney damage. We will continue to collaborate with the FDA during their review process and in parallel build our commercial readiness for a potential approval and commercial launch in the first quarter of 2021.
SLE affects about 445,000 people in the U.S., up to 50% of whom develop Lupus Nephritis. What's more, there are currently no FDA-approved treatments for this disease.
In other words, there's a dire need for Aurinia's Voclosporin, and if approved, this therapy could become a key growth driver for the company. No wonder, then, that investors are bidding up shares of the biotech following the FDA's acceptance of its NDA for Voclosporin.