STAT+: Aurinia secures FDA drug approval for autoimmune kidney disease, with label offering stronger patent protection
Aurinia Pharmaceuticals won approval from the Food and Drug Administration on Friday evening to market a new medicine for patients with lupus nephritis, a serious autoimmune kidney disease. It’s good news for patients, but the nature of the approval also makes it especially good news for Aurinia and investors.
While the approval of the new drug, called Lupkynis, was expected, the FDA allowed Aurinia to include proprietary dosing instructions in its prescribing label. The dosing instructions help physicians tailor Lupkynis treatment for lupus nephritis patients, but they also strengthen and extend the drug’s patent protection.
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