Health Canada Approves ZEPOSIA®, an Oral Treatment for Relapsing Remitting Multiple Sclerosis
(MONTREAL, QC) October 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.[i]
"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. Jiwon Oh, Neurologist and MS specialist. "Today's announcement is exciting because it addresses an unmet need for people when first diagnosed with relapsing-remitting MS. Having an oral treatment with evidence of higher efficacy than some other first-line treatments, and a good safety profile that is well-tolerated to manage clinical exacerbations and whole brain volume loss will be a benefit to people living with MS."
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. Pamela Valentine, president and CEO, MS Society of Canada. "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."
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 Canada as a first-line therapyi,[iv] for the treatment of RRMS. The approval is based on data from the two largest pivotal, head-to-head RRMS studies with an active comparator to date.[v]
“This approval reinforces our commitment to transforming patients’ lives and delivering innovative treatment options,” said Al Reba, General Manager, 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.”
The Health Canada approval is based on data from the randomized, active-controlled Phase 3 SUNBEAM and RADIANCE Part B clinical trials, which enrolled more than 2,600 patients across 150 sites in more than 20 countries.i,iv Key findings from the trials include:
· 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
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
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
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.
For more information, please contact:
Lead, Corporate Affairs
Bristol Myers Squibb Canada
[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.