Health Canada Approves ZEPOSIA?, an Oral Treatment for Relapsing Remitting Multiple Sclerosis
Bristol?Myers Squibb's?medication provides a new oral treatment option for Canadians living with the neurological disease
MONTREAL,?Oct. 7, 2020?/CNW/ - Bristol Myers Squibb announced today that Health Canada approved ZEPOSIA??(ozanimod) for the treatment of patients with relapsing remitting multiple sclerosis (RRMS) to decrease the frequency of clinical exacerbations.- 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 versus AVONEX??(1.84 versus 3.18), a relative reduction of 42 per?cent.i,iv
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 AVONEX??(interferon beta-1a) for at least a 12-month treatment period.?iv?The study included 1,346 people living with RMS across 158 sites in 20 countries.iv 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 AVONEX??(interferon beta-1a) over a 24-month treatment period. The study included 1313 people living with RMS across 150 sites in 21 countries.v 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?Canada?for the treatment of RRMS. ZEPOSIA??binds with high affinity to S1P receptors 1 and 5 to reduce the number of attacks.i?It is taken orally as a capsule, once daily, with or without food.i About Bristol Myers Squibb Canada
Bristol?Myers Squibb Canada?is an indirect wholly-owned subsidiary of Bristol Myers Squibb Company, a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases. Bristol Myers Squibb Canada Co. employs more than 300 people across the country. For more information, please visit?https://www.bms.com/ca/en. About Bristol Myers Squibb
Bristol?Myers Squibb?is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases. For more information about Bristol Myers Squibb, visit us at?BMS.com?or follow us on?LinkedIn,?Twitter,?YouTube,?Facebook?and?Instagram. Celgene and Juno Therapeutics are wholly owned subsidiaries of Bristol-Myers Squibb Company. In certain countries outside the US, due to local laws, Celgene and Juno Therapeutics are referred to as, Celgene, a Bristol Myers Squibb company and Juno Therapeutics, a Bristol Myers Squibb company.
i?ZEPOSIA? Product Monograph. Bristol Myers Squibb. October 2, 2020. |
ii?Multiple Sclerosis Society of Canada. About MS.?https://mssociety.ca/about-ms.?Accessed June 12, 2020. |
iii?Multiple Sclerosis Society of Canada. MS Lesions.?https://mssociety.ca/library/document/MjnK4fDhmUIi9OuLWVcZsJHeTYBzQ0kS/original.pdf.?Accessed June 12, 2020. |
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 Lancet: Neurology. DOI: 10.1016/S1474-4422(19)30239-X. |
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 Lancet: Neurology. DOI: 10.1016/S1474-4422(19)30238-8. |