Roche/Biogen drop development of ocrelizumab in rheumatoid arthritis

19 May 2010

In an announcement that probably comes as no surprise, Swiss drug major Roche and partner USA-based Biogen Idec have decided to discontinue the ocrelizumab clinical development program in patients with rheumatoid arthritis (RA).

Earlier this year, and independent monitor board, based on its assessment of the SCRIPT, FEATURE, FILM and STAGE studies in RA, as well as lupus in BELONG and BEGIN, concluded that the safety risk of the drug outweighs the benefits observed, leading to the suspension of the trial (The Pharma Letter March 8). The review detected an infection-related safety signal which included serious and opportunistic infections, some of which were fatal.

Following a detailed analysis of the efficacy and safety results from the RA program, the companies concluded that the overall benefit to risk profile of ocrelizumab was not favorable in RA taking into account the currently available treatment options.

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