Aurinia Pharmaceuticals Inc. (AUPH)

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.

LN causes irreversible kidney damage and significantly increases the risk of kidney failure, cardiac events, and death. It is one of the most serious and common complications of the SLE, an autoimmune disease. There are approximately 200,000 to 300,000 people with SLE in the United States, with an estimated one-third having already developed LN by the time of the SLE diagnosis. LN disproportionately impacts people of color.

The FDA approval of Lupkynis now provides treating physicians with a new option to treat LN. Prior to the approval of Lupkynis, there were a limited number of therapeutic options to treat the disease, and many of those had toxicity issues. Peter Greenleaf, president, and chief executive officer of British Columbia-based Aurinia, said the approval of Lypkynis marks a turning point for the lupus nephritis community, as well as for Aurinia itself.

“This is an extremely important moment for Aurinia as not only have we achieved the milestone of FDA approval as a company, but we also launched and are currently in market with the first FDA-approved oral therapy for adult patients with active lupus nephritis. The entire Aurinia organization, from research to clinical development, regulatory to commercial teams have worked tirelessly to ensure we can deliver Lupkynis to the patients living with lupus nephritis who have been eager for a new treatment option,” Greenleaf told BioBuzz.

The FDA approved Lupkynis, a calcineurin inhibitor, under Priority Review. The regulatory agency previously awarded Fast Track designation to the drug. Approval was based on data from Aurinia’s Phase III AURORA study and the Phase II AURA-LV clinical trial. Data from both of the studies showed Lupkynis demonstrated the ability to significantly improve outcomes in LN patients after 52 weeks.

Aurinia said patients treated with both Lupkynis and standard-of-care treatment were more than twice as likely to achieve renal response and experienced a decline in urine protein creatinine ratio (UPCR) twice as fast as patients on typical standard-of-care alone. UPCR is a standard measurement used to monitor protein levels in the kidney. Patients treated with Lupkynis showed improved response rates in all parameters across immunologically-active classes of LN studied, the company said.

“People with lupus nephritis have desperately needed approved treatments to help them avoid irreversible kidney damage and the eventual need for kidney transplant,” Stevan W. Gibson, President, and CEO of Washington, D.C,-based Lupus Foundation of America said in a statement. “The approval of a tailored therapy represents a significant step forward in treating lupus nephritis and is excellent news for the lupus community.”

With the approval of Lupkynis, the Rockville manufacturing facility, located in the I-270 life sciences and biotech corridor, will bolster the company’s commercialization plan for the newly-approved LN drug. Greenleaf called the Rockville site a “strategic step” for the company’s long-term growth prospects. As BioBuzz previously reported, there are estimates the manufacturing site could employ up to 500 people.

Aurinia was expected to hire up to 100 employees in the first year and up to 500 employees as the company expands its operations. “We look forward to continuing to tap into the exceptional life sciences talent pool in the BioHealth Capital Region to drive Aurinia’s growth in the U.S. With 40+ employees working in Rockville, as well as more than 130 additional commercial team members operating out of this office, we are excited to grow this team as we work to change the course for patients with autoimmune disease,” Max Donley, Aurinia’s Executive Vice President of Operations and Strategy added.