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. |