Fast on GlaxoSmithKline's heels, Aurinia wins OK to steer a second lupus nephritis drug straight to the market
GlaxoSmithKline’s Benlysta isn’t alone in the small circle of approved lupus nephritis drugs anymore.
Little Aurinia Pharmaceuticals has gotten the green light from the FDA to start marketing its first and only program, voclosporin, under the brand name Lupkynis — something CEO Peter Greenleaf says it’s been ready to do since December.
Regulators went right down to the wire on the decision, keeping the company and the entire salesforce it’s already assembled on its toes.
But they haven’t been idle. In an earlier interview, Greenleaf told Endpoints News that the field team, which totals about 100 to 150 sales reps, has already started talking to physicians about LN and going to medical meetings to present data on voclosporin. By blocking calcineurin, a signaling protein involved in T cell activation, the small molecule oral drug is designed to inhibit IL-2 and tamps down inflammation in the kidney.
The Phase III trial, AURORA, voclosporin plus mycophenolate mofetil and low-dose corticosteroids hit the primary endpoint on renal response at 1-year. It also hit the bar for getting proteinuria, a measurement of active disease, under control.
“I mean, that’s the number 1 treatment goal that physicians search for,” Greenleaf said.
First announced in late 2019, those results were seven years in the making for CMO Neil Solomons, who was part of a team at Vifor Pharma that brought in voclosporin from Isotechnika — it was being developed for kidney transplant rejection at that time — and spun out Aurinia. Even though a previous study he was involved in had cemented mycophenolate mofetil, or MMF, among other unapproved meds as the standard of care, there was really no direct evidence of their treatment effect (They were also “highly toxic,” according to a trial investigator.)
“We’re the first company to do that,” Solomons said, “randomized blinded controlled study with our Phase II trial back in 2016 to actually demonstrate that the drug actually truly works in this area.“
Also among the firsts: a patented dosing protocol that allows patients to titrate down the dose based on an estimate of renal function known as eGFR, and reduction of corticosteroids required in the regimen.
All of those qualities, the company reckons, could give its reps plenty to convince doctors to take on their drug.
Greenleaf added that voclosporin “works very very rapidly,” showing benefit at both the 6-month and 1-year time points that seems comparable to — with the usual caveats about cross-trial comparisons — what Benlysta, a biologic, showed at 2 years.
“Who knows what that means for future treatment — how they’re used alongside of each other, in concert or within the full treatment continuum,” the CEO, who’s run a trio of other biotechs after leaving AstraZeneca’s MedImmune, said. “But today as it exists we think our drug stands very well on its own.”
By their count, the LN patient population in the US is well north of 100,000. With $400 million in cash, Aurinia’s $AUPH commercial team will have ample funding for several years. Otsuka, its new partner, is tasked with scoring OKs and commercializing in the EU, Japan and elsewhere.
Joseph Schwartz of SVB Leerink is a believer. While GSK may have the upper hand at launch, he wrote, voclosporin should eventually “come out on top, as it has superior efficacy as compared to Benlysta”: Aurinia reported a renal response rate of 40.8% versus 22.5% in the control arm while Benlysta’s difference with control was smaller (43% vs 32%).
For 2021, he’s modeling US sales at $87.6 million assuming a price of $35,000.