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news.Horizon Pharma has submitted a New Drug Application (NDA) to the United States Food and Drug Administration (FDA) for Lodotra, for the treatment of Rheumatoid Arthritis.
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Lodotra, which is currently approved for marketing in 16 European countries is a modified (delayed)-release formulation of low-dose prednisone.
Circadian Administration of Prednisone in RA (CAPRA-2), 12-week, double-blind, placebo-controlled Phase 3 trial involving 350 RA patients, led to the NDA submission.
Results from CAPRA-2 showed that an improvement in American College of Rheumatology 20 (ACR20) response criteria for patients who were treated with Lodotra compared to the placebo group.
In addition, an improvement in ACR50 response compared to placebo and an improvement in the more stringent ACR70 response criteria, was also noted.