Aurinia Suspends Voclosporin Development For Dry Eye, Staying Focused On Lupus
Biotech doesn’t shut the door on returning to ophthalmic formulation of the calcineurin inhibitor in dry eye but puts primary focus on oral voclosporin in lupus nephritis, with an FDA approval decision imminent.
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Two drugs that would be the first for lupus nephritis are on the doorstep of the US FDA, a novel drug voclosporin from Aurinia Pharmaceuticals and Benlysta from GlaxoSmithKline.
Canada’s Aurinia Pharmaceuticals expects to file a US NDA in the first half of next year on the use of its next-generation calcineurin inhibitor, voclosporin, in lupus nephritis, a condition with no approved therapies.
Aurinia's voclosporin missed the primary endpoint of superior tolerability compared to Restasis, but hit objective secondary efficacy endpoints that that may better position it for approval in dry eye.