Horizon Therapeutics Public Limited Co (fka HZNP)

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7:01AM Horizon Pharma submits new drug application for LODOTRA for the treatment of Rheumatoid Arthritis (HZNP) 8.20 : Co announced it has submitted a New Drug Application to the United States FDA for LODOTRA, a proprietary modified-release formulation of low-dose prednisone, for the treatment of active rheumatoid arthritis (RA). LODOTRA is currently approved for marketing in 16 European countries. The LODOTRA NDA submission was primarily based on results from the Circadian Administration of Prednisone in RA (CAPRA-2) trial, a pivotal, 12-week, double-blind, placebo-controlled Phase 3 trial involving 350 RA patients.