Roche, Biogen Discontinue Ocrelizumab Program in RA

Roche and Biogen Idec are discontinuing development of ocrelizumab in rheumatoid arthritis (RA) following analysis of the safety efficacy results. The companies concluded that the risk/benefit profile was not favorable in RA taking into account currently available treatment options. Ocrelizumab is also being evaluated in a Phase II study for relapsing remitting multiple sclerosis (RRMS).

The ocrelizumab RA program included four Phase III studies (SCRIPT, FILM, FEATURE, and STAGE). Analysis included available safety and efficacy data from the SCRIPT Phase III study in patients with previous inadequate response to TNF-inhibitors and safety data from the Phase III FILM study in patients who were methotrexate-naïve.

“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.