Bristol Myers Squibb has announced interim results from the phase 3 extension trial DAYBREAK, demonstrating the long-term efficacy and safety profile of Zeposia (ozanimod) in patients with relapsing forms of multiple sclerosis (MS).
Treatment with Zeposia demonstrated a low relapse rate and more than 70% of patients were relapse-free after four years.
Safety was consistent with prior findings and the established safety profile of Zeposia in up to five years of follow-up.
The data is being presented at the 37th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) on 13-15 October 2021.
“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, study investigator and Professor of Clinical Neurology, University of California San Francisco (UCSF) Weill Institute for Neurosciences and clinical research director, UCSF MS Center.
“The 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,” he added.
Zeposia was initially approved by the FDA for the treatment of relapsing forms of multiple sclerosis (RMS) in March 2020, while the European Commission also authorised the drug for the treatment of adult patients with relapsing remitting multiple sclerosis (RRMS) with active disease in May 2020.
“Our presentations at ECTRIMS 2021 bolster the growing body of evidence underscoring the long-term efficacy and safety of Zeposia to treat relapsing forms of MS,” said Jonathan Sadeh, head of Immunology and Fibrosis Development, Bristol Myers Squibb.