Horizon Pharma gets FDA approval of arthritis drug Rayos

The Food and Drug Administration has given approval to Deerfield-based Horizon Pharma’s rheumatoid arthritis drug Rayos for sale in the U.S.

“We are extremely pleased the FDA has approved Rayos for a broad range of indications, including RA and polymyalgia rheumatica,” said Timothy P. Walbert, chairman, president and chief executive officer of Horizon Pharma. “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.”

Rayos, known as Lodotra in Europe, is a proprietary delayed-release formulation of low-dose prednisone.  Rayos is different with an approximately four-hour lag time from that of immediate-release prednisone formulations. Outside the United States, Lodotra is approved for the treatment of moderate to severe active RA when accompanied by morning stiffness in 16 European countries and Israel. Horizon has granted commercialization rights for Lodotra in Europe, Asia and Latin America to its distribution partner Mundipharma International Corporation Limited.