FDA accepts review of Horizon drug Lodotra

DEERFIELD — The Food and Drug Administration has accepted a review of Horizon Pharma Inc.’s Lodotra for sale in the United States.

Lodotra is a proprietary modified formulation of low-dose prednisone, for the treatment of rheumatoid arthritis (RA) in adults. It is currently approved for marketing in 16 European countries.

“The acceptance of the Lodotra NDA for review is an important milestone as we continue our commitment to bringing new therapeutic options to patients suffering from arthritis, pain and inflammatory diseases,” said Timothy P. Walbert, chairman, president and chief executive officer, Horizon Pharma. “We are confident in the data from the Phase 3 program and believe that if approved, Lodotra will address an unmet treatment need for patients with rheumatoid arthritis.”