Policy & Regulation
Bristol Myers Squibb releases up to 5 years positive data for multiple sclerosis drug Zeposia (ozanimod)
14 October 2021 -

Bristol Myers Squibb (NYSE: BMY), an American multinational pharmaceutical company, announced on Wednesday interim results from the Phase 3 open-label extension trial DAYBREAK, demonstrating the long-term efficacy and safety profile of Zeposia (ozanimod) in patients with relapsing forms of multiple sclerosis (MS).

These data and five additional abstracts from company-sponsored studies are being presented at the 37th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS), taking place virtually.

'Early and effective intervention can significantly impact physical and cognitive results over time, with low relapse rates an important indicator of patient outcomes,' said Bruce Cree, M.D., Ph.D., M.A.S., study investigator and Professor of Clinical Neurology, University of California San Francisco (UCSF) Weill Institute for Neurosciences and clinical research director, UCSF MS Center. 'These data from the DAYBREAK trial provide a clear picture of the long-term safety and efficacy profile of Zeposia, and reinforce its potential when used early in the treatment process for people living with relapsing forms of MS.'

The company said that in the DAYBREAK extension study, safety was consistent with prior findings and no new safety signals emerged during the reporting period with long-term use of Zeposia. Treatment with Zeposia demonstrated a low annualised relapse rate (ARR) of 0.103. At months 36 and 48, 75% and 71% of participants were relapse-free and 3- and 6-month confirmed disability progression was observed in 13.9 percent and 11.4% of participants in the trial, respectively.

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