FDA approves Rayos
DEERFIELD, Ill. — Horizon Pharma announced it has received regulatory approval from the Food and Drug Administration for one of its drugs.
The drug maker said Rayos (prednisone) delayed-release tablets — in the 1-mg, 2-mg and 5-mg stregnths — were approved for the treatment of rheumatoid arthritis, polymyalgia rheumatica, psoriatic arthritis, ankylosing spondylitis, asthma and chronic obstructive pulmonary disease.
"We are extremely pleased the FDA has approved Rayos for a broad range of indications, including RA and polymyalgia rheumatica," Horizon Pharma chairman, president and CEO Timothy Walbert said. "Our initial focus will be on the launch of Rayos in rheumatologic diseases, such as RA and polymyalgia rheumatica, in the fourth quarter of this year. Based on the extent of the approved indications, we will be developing a broader commercial strategy to expand the opportunity for Rayos in key IL-6 mediated diseases, including asthma and COPD."