09.03.10
Roche and Biogen Idec suspend Ocrelizumab in RA over side effects
Basel – Roche and Biogen Idec have suspended development of its humanised anti-CD20 monoclonal antibody Ocrelizumab in Rheumatoid Arthritis (RA).The decision follows the recommendation of the independent Ocrelizumab RA & Lupus Data and Safety Monitoring Board (DSMB) based on their assessment of the studies in rheumatoid arthritis and lupus erythrematosus.The DSMB concluded that the safety risk of the rituximab successor outweighs the benefits observed in these specific patient populations at this time. Their review detected an infection-related safety signal which included serious and opportunistic infections, some of which were fatal. Ocrelizumab is also being evaluated for Relapsing Remitting Multiple Sclerosis (RRMS), which remains in Phase II clinical studies.