Victoria pharmaceutical firm Aurinia is one step closer to bringing to market its treatment for lupus nephritis after submitting a new drug application to the Food and Drug Administration in the U.S.
Aurinia, which late last year released what it called “fantastic” results of third-stage clinical trials for its drug Voclosporin, is waiting to hear if it can start producing the drug for patients in the U.S.
“Outside of [final FDA] approval this is the biggest thing this company has accomplished,” co-founder Mike Martin said Tuesday. “This has been a decade in the making.”
Voclosporin has been tested and found to be effective in trials for the treatment of a kidney inflammation caused by the autoimmune disease lupus. Lupus nephritis, which affects about three million people worldwide, can lead to kidney damage, kidney failure and death.
The drug could be the first FDA-approved therapy for lupus nephritis.
“It’s amazing and pretty satisfying,” said Martin, who founded Aurinia with Neil Solomons and Richard Glickman.
Martin said they expect there will be a back-and-forth with the FDA over the next few months, but there is reason to believe Voclosporin could be on the market by this time next year.
He said there is a lot of market research and preparation work ongoing in anticipation of approval.
Aurinia, which had about 30 employees late last year, now has more than 100 workers and has established its commercial hub in Maryland.
The submission to the FDA includes a request for “priority review” which, if granted, would shorten the FDA’s review of the application to eight months from the time of submission. The standard review is 12 months.
“[Lupus nephritis] is a severe and debilitating consequence of lupus, which can severely impact the quality of life of individuals struggling with this disease. The Aurinia team continues to work incredibly hard toward delivering the first FDA approved treatment option for those affected by [it] in the hope of changing the course of this disease,” said Peter Greenleaf, Aurinia’s chief executive in a statement.
Aurinia has been on a wild ride since the phase-three clinical trial results were released in December.
The company’s stock price skyrocketed to nearly $30 Cdn per share immediately after the trial results were released in December. They had been trading around the $11-per-share mark the day before.
Tuesday, Aurinia’s stock price (TSX:AUP) closed at $21.96, giving it a market capitalization of $2.47 billion — the total value of a company’s shares.
Martin said the company is looking to find partners in Europe and Japan to take Voclosporin to market. He anticipates those processes will be about nine months behind the FDA.