Aurinia Pharmaceuticals (NASDAQ:AUPH)

Lupkynis 1st oral drug to treat lupus nephritis. May be a game changer. Also likely takeover candidate

Aurinia has successfully advanced a drug for this condition through Phase 3 trials. The company’s drug, called voclosporin, works by inhibiting an enzyme called calcineurin. Calcineurin activates inflammatory molecules and T cells, and drugs of this class have been used to treat a range of autoimmune diseases.

Voclosporin, however, has a number of advantages over other drugs of this class. These include increased potency and lower diabetes risk. Moreover, after a year of treatment, patients in the Phase 3 trial were almost twice as likely (22% vs. 40.8%) to achieve a positive renal response over patients receiving the current standard-of-care treatment.[2]

Patients were evaluated using urine analysis and voclosporin patients were much more likely to see a reduction of biomarkers like proteins in urine, to healthier levels.

That’s important. This indicates that the drug is reducing kidney inflammation and helping to protect the vital organ from damage.

These good results released late last year enabled Aurinia to file a New Drug Application with the FDA earlier this year. The regulator has not only accepted this small drug company’s application, but it’s agreed to grant it Priority Review status. This indicates that the FDA considers this drug to be important enough to warrant an expedited review process.

Priority Review sets a six-month target for a final decision on whether or not a new drug is approved. Aurinia announced that its application was accepted on June 21, so that means we can expect an FDA decision by Jan. 22, 2021.