Horizon Pharma Submits NDA for RA Drug
The NDA submission is based on results from a 12 week double-blind placebo-controlled Phase 3 trial involving 350 rheumatoid arthritis patients.
Arthritis-treatment developer Horizon Pharma has submitted a new drug application (NDA) to the FDA for Lodotra, for the treatment of rheumatoid arthritis.
Lodotra is a modified (delayed)-release formulation of low-dose prednisone and is currently approved for marketing in 16 European countries.
The NDA submission by Horizon is based on results from Circadian Administration of Prednisone in RA (CAPRA-2), a 12 week double-blind placebo-controlled Phase 3 trial involving 350 RA patients.
Results from CAPRA-2 demonstrated an improvement in American College of Rheumatology 20 (ACR20), ACR50 and ACR70 response criteria for patients who were treated with Lodotra compared to the placebo group. <
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