"We thank the investigators and patients who participated in the RA clinical studies. Although this outcome is disappointing for patients, Roche remains committed to the development of treatments for RA," said Hal Barron M.D., executive vice president, Global Development and chief medical officer, Roche.
In March, Roche and Biogen Idec announced the suspension of treatment in the ocrelizumab RA program. This decision followed a recommendation from the independent ocrelizumab RA & Lupus Data and Safety Monitoring Board (DSMB). The DSMB concluded that the safety risk outweighed the benefits observed in these specific patient populations at that time based on an infection related safety signal which included serious infections, some of which were fatal, and opportunistic infections. Subsequently, the U.S. Food and Drug Administration (FDA) placed the RA studies on clinical hold.
SOURCE Roche and Biogen Idec