"Ongoing treatment with disease-modifying therapy in people living with multiple sclerosis can reduce the number of relapses and new brain lesions that form, but each person responds differently to different treatments. This is why having another treatment with meaningful efficacy to help decrease relapses and brain lesions is important," said Dr.
Multiple sclerosis (MS) is an autoimmune disease of the central nervous system (CNS) that attacks the protective myelin sheath that covers the nerves; ii this causes inflammation and often damages the myelin in patches called lesions. iii When this happens, the normal flow of nerve impulse is delayed or blocked, leading to symptoms.iii
RRMS is characterized by unpredictable clinical exacerbations manifested by relapses (also known as attacks, exacerbations or flare-ups) and accumulation of lesions in the CNS during which new symptoms appear or existing ones get worse.ii
"Multiple sclerosis is an unpredictable neurological disease that impacts more than 77,000 Canadians," said Dr.
ZEPOSIA® is an oral medication taken daily that helps protect against attacks on the nerves by stopping some of the body's white cells ('lymphocytes') reaching the brain and spine where they could cause inflammation and damage to myelin, the nerves protective coating.i It is the only oral selective sphingosine-1-phosphate (S1P) receptor modulator approved in
"This approval reinforces our commitment to transforming patients' lives and delivering innovative treatment options," said
The
- ZEPOSIA® (0.92 mg) demonstrated a relative reduction in ARR versus
AVONEX ® of 48 per cent through one year in the SUNBEAM study and 38 per cent at two years in the RADIANCE study (absolute ARR of 0.18 versus 0.35 and 0.17 versus 0.28, respectively).i,v,iv - At one year in the SUNBEAM study, treatment with ZEPOSIA® reduced the number of T1– weighted gadolinium-enhanced (GdE) brain lesions more than
AVONEX ® (0.16 vs 0.43), a relative reduction of 63 per cent, and reduced the number of new or enlarging T2 brain lesions (1.47 versus 2.84), a relative reduction of 48 per cent.i,iv - At two years in the RADIANCE study, treatment with ZEPOSIA® reduced the number of T1– weighted GdE brain lesions more than
AVONEX ® (0.18 versus 0.37), a relative reduction of 53 per cent. ZEPOSIA® also reduced the number of new or enlarging T2 lesions versusAVONEX ® (1.84 versus 3.18), a relative reduction of 42 per cent.i,iv
About Multiple Sclerosis
Multiple sclerosis is a disease in which the immune system attacks the protective covering of the nerves, called myelin, causing inflammation and damage. Myelin is necessary for the transmission of nerve impulses.ii
Relapsing-remitting MS (RRMS) is characterized by unpredictable but clearly defined relapses (also known as attacks, exacerbations or flare-ups) during which new symptoms appear or existing ones get worse. Approximately 85 per cent of people with MS are initially diagnosed with RRMS.ii
Canada has one of the highest rates of multiple sclerosis in the world, with an estimated 77,000 people living with the disease. While it is most often diagnosed in young adults aged 20 to 49, younger children and older adults are also diagnosed.ii
About SUNBEAM™
SUNBEAM is a pivotal, phase 3, multicentre, randomized, double-blind, double-dummy, active-controlled trial evaluating the efficacy, safety and tolerability of oral ZEPOSIA® (0.92 mg and 0.46 mg, equivalent to 1 mg and 0.5 mg ozanimod HCI, respectively) against weekly intramuscular
The primary endpoint of the trial was annualized relapse rates (ARR) during the treatment period.iv The secondary MRI endpoints included the number of new or enlarging hyperintense T2-weighted brain MRI lesions over 12 months and number of gadolinium-enhanced brain MRI lesions at month 12.iv
About RADIANCE™
RADIANCE Part B is a pivotal, Phase 3, multicentre, randomized, double-blind, double- dummy, active-controlled trial evaluating the efficacy, safety and tolerability of two doses of oral ZEPOSIA® (0.92 mg and 0.46 mg, equivalent to 1 mg and 0.5 mg ozanimod HCI, respectively) against weekly intramuscular
The primary endpoint of the trial was ARR over 24 months.v The secondary MRI endpoints included the number of new or enlarging hyperintense T2-weighted brain MRI lesions over 24 months and the number of MRI T1 gadolinium-enhancing lesions at 24 months.v
About ZEPOSIA® (ozanimod)
ZEPOSIA® (ozanimod) is for the treatment of patients with relapsing remitting multiple sclerosis (RRMS) to decrease the frequency of clinical exacerbations.i It is the only first line sphingosine-1-phosphate (S1P) receptor modulator approved in
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i ZEPOSIA® Product Monograph. |
ii Multiple Sclerosis Society of Canada. About MS. https://mssociety.ca/about-ms. Accessed |
iii Multiple Sclerosis Society of Canada. MS Lesions. https://mssociety.ca/library/document/MjnK4fDhmUIi9OuLWVcZsJHeTYBzQ0kS/original.pdf. Accessed |
iv Comi, G, Kappos, L, Selmaj, KW, et at. Safety and efficacy of ozanimod versus interferon beta-1a in relapsing multiple sclerosis (SUNBEAM): a multicenter, randomized, minimum 12-month, phase 3 trial. The |
v Cohen, JA, Comi, G, Selmaj, KW, et al. Safety and efficacy of ozanimod versus interferon beta-1a in relapsing multiple sclerosis (RADIANCE): a multicenter, randomized, 24-month, phase 3 trial. The |
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