Aurinia adds icing to the cake with clean lupus approval

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It has been plain sailing for Aurinia since voclosporin demonstrated impressive efficacy in lupus nephritis back in October 2019, and this continued on Friday with an on-time US approval, complete with exactly the label the company wanted. Prescribing information specifies a dosage and administration schedule that the company believes should help secure a patent that affords exclusivity out to 2037. Lupus nephritis afflicts around 40% of lupus sufferers and causes irreversible kidney damage; voclosporin is the first oral treatment to offer the prospect of preventing this organ damage. All of this adds up to a bright commercial future, reckons the sellside, which projects blockbuster sales by 2026, according to EvaluatePharma. Aurinia shares jumped 32% this morning, giving the company a $2.5bn market cap; the company is already considered a takeover target, and the prospect of a long, patent-protected revenue stream theoretically makes such an outcome more likely. There are several big names investigating various re-purposed therapies in lupus nephritis, and voclosporin, now branded Lupkynis, arguably raises the bar for those coming behind. Those that want in on this space will surely have been monitoring Aurinia’s progress.

Selected projects in development for lupus nephritis
Project Company  Trial detail Results/ primary completion
Anifrolumab (anti-interferon type I MAb)* Astrazeneca Tulip-LN1 (NCT02547922) Results due Q2 2021
CFZ533 (iscalimab; anti-CD40 MAb) Novartis  NCT03610516 Mar 2021
BI 655064 (anti-CD40 MAb)** Boehringer Ingelheim NCT03385564 May 2021
KZR-616 (immunoproteasome inhibitor) Kezar Life Sciences NCT03393013 Jan 2022
Guselkumab (anti-IL-23 MAb) J&J  Orchid-LN (NCT04376827) Dec 2022
Obinutuzumab (Gazyva; anti-CD20 MAb)  Roche Regency (NCT04221477) Oct 2023
Deucravacitinib (BMS-986165; Tyk2 inhibitor) Bristol Myers Squibb NCT03943147 Jan 2023
Secukinumab (Cosentyx; anti-IL-17A MAb) Novartis  NCT04181762 Feb 2025
*Filed in SLE; **abandoned elsewhere. Source: EvaluatePharma.

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