The United States Food and Drug Administration (FDA) approved Rayos on July 26, 2012 for the treatment of rheumatoid arthritis, polymyalgia rheumatica, psoriatic arthritis, ankylosing spondylitis, asthma and chronic obstructive pulmonary disease. Rayos, which is known as Lodotra in Europe, is a delayed-release formulation of prednisone.
Rayos, manufactured by Horizon Pharma, Inc., will be available in 1 mg, 2 mg and 5 mg strengths. The FDA based its approval on results from the CAPRA-1 and CAPRA-2 trials. The CAPRA-2 trial showed that patients with moderate to severe rheumatoid arthritis treated with Rayos achieved a statistically significant improvement in ACR20 response criteria compared to placebo. The CAPRA-1 trial provided evidence of the drug's safety.
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