"Reduce damage and strengthen repair"! The treatment of multiple sclerosis (RMS) in the treatment of Peposia has long-term efficacy and safety!

September 02, 2020 // -- BMS recently announced the new drug Zeposia (100) for multiple sclerosis at the 8th Joint ACTRIMS-ECTRIMS Conference of msVirtual 2020 Conference The interim results of the Ozanimod 3 open label extension trial DAYBREAK confirmed Zeposia's long-term efficacy and safety in patients with multiple sclerosis (RMS): most patients did not relapse during the 24th and 36th months of treatment and did not have new safety issues.
, the DAYBREAK trial represents the longest safety and efficacy analysis ever performed on Zeposia in RMS patients.
the trial included 2,494 patients who had previously completed Zeposia Phase 1, Phase 2, and Phase 3 clinical trials, with an average duration of 35.4 months in the DAYBREAK trial.
that there were no new security issues with Zeposia in this extended study.
in the 24th and 36th months of treatment, 79% and 75% of patients did not relapse.
, only 10.8 per cent and 8.6 per cent of patients observed three and six months of confirmed progression in disability (CDP).
Regardless of the treatment group in the mother trial (RADIANCE, SUNBEAM, RPC01-1001 clinical studies), the average number of new/expanded T2 lesions at the 24th month of treatment was similar, as was the average number of GdE lesions at the 24th month of treatment.
in the DAYBREAK trial, 2,494 patients were exposed to Zeposia for 35.4 months, of which 2,039 patients (81.8%) had adverse therapeutic events (TEAE), 236 (9.5%) had severe TEAE (SAE), and 56 (2.2%) had discontinued the study due to TEAE.
most common TEAEs were nasopharyngitis (17.9%), headache (14%), upper respiratory tract infections (9.9%) and lymphocyte reduction (9.6%).
no serious opportunity infections, and the incidence of exposure-adjusted TEAE and SAE decreases over time.
The in-depth understanding of long-term outcomes allows clinicians to determine the best treatment for patients with multiple sclerosis," said Bruce Cree, lead investigator on the study and professor of clinical neurology at the Will Institute of Neuroscience at the University of California, San Francisco.
dayBREAK trials provide us with an important background on the long-term efficacy and safety of Zeposia. "At MSVirtual 2020, we are pleased to share new discoveries and extensive research results from DAYBREAK that have accelerated our understanding of the recurrence of multiple sclerosis and added new elements to our growing knowledge system about Zeposia," said Dr. Mary Beth Harler, Director of Immunology and Fibrosis Development at
.
Together with our industry-leading collaborators, we are working on new endpoints, brain volumes, and cognitive abilities that may help us better understand the safety and effectiveness of Zeposia and promote the translational science of multiple sclerosis patients experiencing this unpredictable debilitating disease."
" multiple sclerosis (MS) is a disease in which the immune system attacks protective myelin that covers the nerves.
damage can disrupt communication between the brain and other parts of the body.
, the nerve itself may deteriorate, a process that is currently irreversible.
multiple sclerosis affects about 2.5 million people worldwide and about 700,000 people in Europe.
Zeposia's active pharmaceutical ingredient ozanimod is an oral S1P subject regulator that selectively binds S1P1 and S1P5 with high affinity.
ozanimod selective binding S1P1 is thought to inhibit the migration of activated lymphocytes from a specific subse group to the inflammatory region, reducing levels of circulating T lymphocytes and B lymphocytes that can lead to anti-inflammatory activity, thereby relieving the immune system's attack on neuromalics.
immune surveillance function of patients is maintained due to the special action of ozanimod.
combination of ozanimod and S1PR5 activates specific cells in the central nervous system, promotes myelin regeneration, and prevents synapse defects, ultimately preventing nerve damage.
ozanimod has the potential to improve the symptoms of multiple immune diseases through the combination of the two mechanisms of "injury reduction and enhanced repair".
U.S., Zeposia was approved in March to treat adult multiple sclerosis (RMS), including clinical isolation syndrome, relapsed remission-relieving diseases, and active secondary progressive diseases.
in the European Union, Zeposia was approved in May this year to treat adult patients with relapsed-remission-relieving multiple sclerosis (RRMS) with active diseases (defined as clinical or imaging characteristics).
clinical data show that Zeposia treatment will reduce annual recurrence rate (AAR) by 48% in one year and AAR by 38% in 2 years of treatment compared to Avonex (interferon beta-1a).
zeposia also reduced the number of brain injuries and lesions compared to Avonex, showing a decrease in the percentage change in total brain capacity (WBV) relative to the baseline.
Zeposia, developed by New Base, also marks the first drug approved in the U.S. and the European Union for the assets acquired since the acquisition of The New Base, and will expand Therman's franchise in immunology.
Origin: Bristol Myers Squibb Announces Interim Results from Long-Term Study StudyIng Efficacy and Safety Profiles of Zeposia (ozanimod) in Patients with Relapsing Forms of Multiple Sclerosis.