ANUrinia Pharmaceuticals obtained approval from the Food and Drug Administration late on Friday to market a new drug for patients with lupus nephritis, a severe autoimmune kidney disease. It is good news for patients, but the nature of the approval is also good news for Aurínia and investors.
Although approval for the new drug, called Lupkynis, was expected, the FDA allowed Aurinia to include exclusive dosing instructions on its prescription label. Dosing instructions help doctors define the treatment of Lupkynis for patients with lupus nephritis, but they also strengthen and extend the drug’s patent protection.
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