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Aurinia Pharmaceuticals Inc. has been approved by the U.S. Food and Drug Administration to sell its drug for a severe form of lupus, a rare milestone for a Canadian biotechnology company.

The Victoria-based company said late Friday its drug Lupkynis, formerly known as voclosporin, had been approved for use in combination with immunosuppressive therapies to treat adults with lupus nephritis (LN), a variant of lupus that occurs when the immune system attacks the kidneys, often causing kidney failure and death. Until recently there was no FDA-approved treatment.

The FDA approval “marks a turning point for the lupus nephritis community,” Aurinia chief executive Peter Greenleaf said in a release. “We are thrilled to bring Lupkynis to the people impacted by this devastating condition.”

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It’s a rare win for the Canadian drug development sector, which hasn’t produced an FDA-approved “major branded product … for a major disease from a truly Canadian innovation in well over a decade,” said Beni Rovinski, managing director with Toronto’s Lumira Ventures, an early backer.

Brian Bloom, CEO of Toronto-based health care boutique investment bank Bloom Burton, said fewer than 10 Canadian companies had received FDA approval for a novel drug, and “of the ones approved this has the potential to be one of the biggest sellers. This is absolutely monumental.”

Aurinia’s 357-patient study in December, 2019, found those who took voclosporin were nearly twice as likely as those on a placebo to show improved kidney health. “People with [LN] have desperately needed approved treatments to help them avoid irreversible kidney damage and the eventual need for a kidney transplant,” Steve Gibson, CEO of the Lupus Foundation of America, said in a release. He called Lupkynis “a much needed oral treatment option to address the challenges faced by people living with LN.”

Biotechnology developers often sell out before getting to commercialization, or license out go-to-market activities to pharmaceutical giants. While it has struck a deal with Japan’s Otsuka Pharmaceutical Co., Ltd, to commercialize voclosporin in Japan, Britain and seven European countries, Aurinia plans to sell the drug itself in the lucrative U.S. market, a rarity for a Canadian biotech company.

Aurinia has spent the past year gearing up to get its drug in market within days of FDA approval, expanding its ranks to 300 people, hiring sales and support staff to educate doctors and advocacy groups, ensure patient access and work on reimbursement. Despite that, Mr. Greenleaf said this month Aurinia would be open to a “table-clearing [takeover] offer.”

The company has raised nearly US$400-million from investors in the past 13 months and got a US$50-million payment from Otsuka; it will get more as the drug advances to market in Otsuka’s territories.

Aurinia was founded by three former executives of Victoria-based Aspreva Pharmaceuticals Corp.: Mr. Greenleaf’s predecessor Richard Glickman; chief business officer Michael Martin; and chief medical officer Neil Solomons. Aspreva had worked to develop a treatment for LN. It was sold in 2008 and the trio left to start Aurinia’s forerunner. Mr. Rovinski said Lumira invested $6-million in 2013 when “not a single other health care venture capitalist … would engage.”

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Foreign investors followed after the group licensed voclosporin, originally developed to prevent organ-transplant rejections, from Edmonton’s Isotechnika Pharma Inc., then did a reverse takeover of Isotechnika. Aurinia listed on Nasdaq in 2015 and had a US$1.9-billion market cap as of Friday.

Lupus mainly affects women of childbearing age and of African, Latin American and Asian descent. Treatment has typically involved a mix of steroids and cancer drugs; side effects include loss of hair, vision and mobility, thinning of bone marrow, lethargy, nausea, anemia and depression.

Mr. Greenleaf has said Aurinia is not sure yet of its potential market size, though it believes its U.S. customer base could be in the high tens of thousands of people. The drug is expected to cost tens of thousands of dollars annually per patient, which may affect user numbers. Aurinia said it launched a support program to help patients “in navigating insurance and … medication costs.”

Aurinia has competition. GlaxoSmithKline PLC’s Benlysta – an intravenously-administered treatment for lupus – got FDA approval last month for use against LN. Roche Holding AG is also developing a LN drug. Aurinia stock closed Friday at US$14.86 on Nasdaq, down 2 per cent, in advance of the news.

Aurinia’s approval follows a historic 2020 for Canada’s biotech sector, which set records for public and private funding, including COVID-19 treatment developer AbCellera Biologics Inc.’s initial public offering last month.

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