Aurinia has nabbed its first FDA approval with an OK for Lupkynis (voclosporin) to treat lupus nephritis, or kidney inflammation caused by systemic lupus erythematosus. And now it'll look to its newly bolstered commercial team to take the drug into a wide-open market.
The FDA late Friday greenlighted Aurinia's drug, a calcineurin inhibitor that blocks IL-2 protein inflammation and stabilizes kidney cells that can be damaged in patients who have advanced lupus nephritis.
In its phase 3 trial, patients who received Lupkynis, rather than placebo, on top of standard immunosuppressants had a higher renal response rate at 52 weeks. Aurinia also reported statistically significant results against a clutch of secondary endpoints, showing Lupkynis started outperforming placebo within 24 weeks and brought the urinary protein-to-creatinine ratio down faster.
Aurinia estimates that of the half-million lupus patients in the U.S., about 80,000 to 100,000 progress to lupus nephritis, which can lead to kidney failure, dialysis, transplant and even death. The company estimates a similarly sized group of potential patients in Europe.
“We’re excited to bring a drug with great data to the market and bring a new drug to Aurinia, but more importantly bring a new product to this patient population that really hasn’t had anything up until this point,” Aurinia President and CEO Peter Greenleaf said.
Aurinia spent 2020 building its commercial operations, boosting employees from fewer than 50 to now more than 300, concentrating on the U.S., Greenleaf said. About 100 to 150 of those are customer-facing sales and medical team reps. The pharma also signed a deal with Otsuka Pharmaceutical to market Lupkynis globally, beginning in Europe and Japan.
The initial targets are rheumatologists and nephrologists, whom Aurinia reps have been talking to and supplying with educational materials for several months, Greenleaf said. That effort includes an HCP-targeted disease awareness campaign, "Time Is Nephrons."
Among that group, Aurinia has “good wind in our sails” as those doctors generally agree that aggressive treatment to reduce protein-to-creatinine ratios in lupus nephritis patients is needed, he said.
Aurinia's nod follows on the heels of a go-ahead for GlaxoSmithKline’s Benlysta, which received a supplemental biologic license to treat lupus nephritis in December. Benlysta was approved in 2011 and is the sole biologic approved to treat systemic lupus erythematosus.
So, while Aurinia’s Lupkynis will compete with the broader Benlysta, it has an advantage the pharma plans to highlight with doctors and patients. Lupkynis begins working faster, Greenleaf pointed out; Benlysta's lupus nephritis data showed a primary efficacy renal response at two years.
Meanwhile, though, more competition is on the horizon as Roche studies blood cancer med Gazyva in lupus nephritis specifically and AstraZeneca trials anifrolumab in systemic lupus erythematosus.