Approval does not assure that Zeposia will be available to Canadian patients at no or low cost, as publicly funded prescription plans are largely administered by each of the country’s 13 provinces and territories.
“Multiple sclerosis is an unpredictable neurological disease that impacts more than 77,000 Canadians. With Canada having one of the highest prevalence rates in the world and no one size fits all approach to treatment, we want to continue seeing innovation and are pleased that there will be another effective oral treatment option,” Pamela Valentine, PhD, president and CEO of MS Society of Canada, said in a press release.
Multiple sclerosis (MS) is caused by the body’s immune system erroneously attacking the nervous system. Zeposia, which is marketed by Bristol Myers Squibb (BMS), is a sphingosine-1-phosphate (S1P) receptor modulator that is believed to work by “trapping” immune cells in lymph nodes. This prevents these cells from entering the nervous system and causing damage.
“This approval reinforces our commitment to transforming patients’ lives and delivering innovative treatment options,” said Al Reba, general manager at Bristol Myers Squibb Canada.
“Bringing to market a new oral treatment option for multiple sclerosis, a disease that impacts so many Canadians, gives us the opportunity to help improve the future for younger higher-functioning MS patients who need to maintain high physical and cognitive ability,” Reba added.
Zeposia’s regulatory approvals were based on positive data from two global Phase 3 clinical trials: SUNBEAM (NCT02294058) and RADIANCE part B (NCT02047734). The trials were conducted across 150 sites in more than 20 countries, and both were sponsored by Celgene, which is owned by BMS.
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