Aurinia Wins FDA Approval for First LN Oral Drug

Aurinia Pharmaceuticals’ Rockville, Maryland commercial center is about to get a whole lot busier following the U.S. Food and Drug Administration’s approval of the company’s treatment for adult patients with active lupus nephritis (LN).

The FDA greenlit Aurinia’s Lupkynis (voclosporin) in combination with a background immunosuppressive therapy regimen for LN, a serious progression of systemic lupus erythematosus (SLE), a chronic, complex and autoimmune disease. The approval not only marks the first medication in the United States specifically approved for active LN, but it also marks the first for Aurinia, which is headquartered in Canada and last year opened its 30,000 square-foot commercialization facility in the BioHealth Capital Region.