On the eve of potential approval of what could be the first U.S. Food and Drug Administration-approved therapy for kidney inflammation caused by the autoimmune disease lupus, Victoria-based Aurinia Pharmaceuticals has launched an awareness campaign in the U.S.
The campaign 鈥� Time is Nephrons 鈥� was launched this fall with the goal of driving home to health-care professionals the importance of active screening and early detection of the disease to minimize the impact on kidney function and improve long-term outcomes for patients.
Aurinia鈥檚 chief medical officer, Neil Solomons, said it鈥檚 a huge undertaking and has meant the company鈥檚 ranks have swelled by about 300 people from 40 at this time last year.
鈥淏ecause we don鈥檛 have [approval] yet, all we can do is create awareness,鈥� said Solomons, noting the hope is that doctors will associate Aurinia with the disease.
Solomons said the campaign name, Time is Nephrons, refers to the cells in kidneys that can be damaged by lupus nephritis.
鈥淭reat them early or you lose them,鈥� he said.
This year, Aurinia announced that the FDA had granted an expedited review of its drug Voclosporin, and Aurinia expects it may be able to launch the treatment in the U.S. by Jan. 22.
Voclosporin has been found to be effective in trials for the treatment of lupus nephritis, which affects about three million people worldwide and can lead to kidney damage, kidney failure and death.
Voclosporin could be the first FDA-approved therapy for the condition.
The company recently released 2020 financial statements showing it posted a loss of $80 million through the first nine months of this year. This year鈥檚 net loss is significantly higher than 2019鈥檚 $47-million loss.
According to financial statements, that鈥檚 due to an increase in business-development expenses related to preparing for the launch of Voclosporin.
Chief executive Peter Greenleaf said Aurinia is focused on being 鈥渇ully prepared鈥� for a potential launch by year-end, as the Jan. 22 date approaches.
鈥淚n addition to preparing for commercialization, we continue to evaluate opportunities to strengthen the development pipeline,鈥� Greenleaf said.
While research and development costs were reduced this year by about $10 million, Aurinia spent $57.7 million on corporate, administrative and business development compared with $14.9 million in the same time period last year.