Roche, Biogen Halt Ocrelizumab Treatment
BASEL, Switzerland (
) --
Roche
and
Biogen
(BIIB) - Get Report
have suspended treating rheumatoid arthritis sufferers with Ocrelizumab treatment after the drug caused deaths.
The decision follows a recommendation of the independent Ocrelizumab RA & Lupus Data and Safety Monitoring Board based on the board's assessment of the studies in rheumatoid arthritis and lupus.
Roche and Biogen said the safety board concluded that the safety risk outweighs the benefits observed in these specific patient populations. The DSMB review detected an "infection related safety signal which included serious and opportunistic infections, some of which were fatal."
"Patient safety is of the utmost importance in all of our drug development programs," said Dr. Hal Barron, Roche's executive vice president and chief medical officer at Roche. "In light of the DSMB recommendations we have decided to suspend Ocrelizumab treatment in the RA clinical development program."
-- Reported by Joseph Woelfel in New York.
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