• The Scottish Medicines Consortium (SMC) has accepted Bristol Myer Squibb’s (BMS) Zeposia® (ozanimod) for the treatment of adult patients with relapsing remitting multiple sclerosis (RRMS) with active disease as defined by clinical or imaging features1
• After the initiation of treatment2 , ozanimod provides patients with a treatment option which may reduce the need to have treatment administered in a clinical setting3
• There are over 15,000 multiple sclerosis (MS) patients in Scotland which has one of the highest rates of MS in the world4
(Uxbridge, Middlesex, [8 th February 2021]) Today, the Scottish Medicines Consortium (SMC) announced it has accepted Bristol Myer Squibb’s Zeposia® (ozanimod) for use in Scotland, for the treatment of adult patients with relapsing remitting multiple sclerosis (RRMS) with active disease as defined by clinical or imaging features. The SMC conclude that ozanimod is a cost-effective treatment1 and RRMS patients in Scotland will be the first in the UK to have access to the treatment.
Today, there are around 15,700 MS patients in Scotland, which has one of the highest rates of MS in the world.4 MS is a condition caused by the body’s own immune system attacking the nervous system, effecting the brain and spinal cord. This can cause a range of symptoms including blurred vision, cognitive impairment, and difficulties with movement.5 Someone with RRMS will have episodes of new or worsening symptoms, known as relapses. These typically worsen over a few days, last for days to weeks to months, then slowly improve over a similar time period. Many treatment strategies try to reduce relapses and halt the progression of the disease to minimise impact on the patients.5
As a result of the Covid-19 pandemic, a recent survey found 57% people were worried about attending face to face appointments in hospital.6 Ozanimod is an oral, once daily treatment 2 , and following treatment administration can be taken at home which could help relieve the need to attend treatment administration in a hospital setting. 3
This approval is based on data from two pivotal, head-to-head relapsing MS studies (SUNBEAM and RADIANCE) which together investigated ozanimod in more than 2,600 adults. Ozanimod demonstrated a relative reduction in annualised relapse rate (ARR) versus interferon beta-1a of 48% through one year and 38% at two years (absolute ARR of 0.18 versus 0.35 and 0.17 versus 0.28, respectively).7,8 Ozanimod was generally well tolerated across both head-to-head Phase III clinical trials, with 90% of patients completing the studies. 7,8
“We are pleased that ozanimod has been accepted for use for the treatment of RRMS patients in Scotland,” said Dr. Hubert Bland, Executive Medical Director at BMS UK & Ireland. “It is a positive step to offer patients an additional oral therapy to help in the management of their disease, particularly with the NHS facing the most challenging period in its history. BMS continues to keep patients at the heart of what we do, and we hope ozanimod will improve the quality of life for MS patients.”
About Ozanimod2
Ozanimod is a sphingosine 1-phosphate (S1P) receptor modulator that binds with high affinity to S1P receptors 1 and 5. Ozanimod blocks the capacity of lymphocytes to egress from lymph nodes, reducing the number of lymphocytes in peripheral blood. The mechanism by which ozanimod exerts therapeutic effects in multiple sclerosis is unknown but may involve the reduction of lymphocyte migration into the central nervous system.
About SUNBEAM7
SUNBEAM is a pivotal, phase 3, multicentre, randomised, double-blind, double-dummy, active-controlled trial evaluating the efficacy, safety, and tolerability of oral ozanimod (0.92 mg, equivalent to 1 mg) against weekly intramuscular interferon beta-1a for at least a 12-month treatment period. The study included 1,346 people living with RRMS across 152 sites in 20 countries.
About RADIANCE8
RADIANCE Part B is a pivotal, phase 3, multicentre, randomised, double-blind, double-dummy, active-controlled trial evaluating the efficacy, safety, and tolerability of oral ozanimod (0.92 mg, equivalent to 1 mg) against weekly intramuscular interferon beta-1a over a 24-month treatment period. The study included 1,320 people living with RMS across 147 sites in 21 countries.
1 Scottish Medicines Consortium. Detailed Advice Document (DAD) – Ozanimod (Zeposia®) for the treatment of adult
patients with relapsing remitting multiple sclerosis (RRMS) with active disease as defined by clinical or imaging features
SMC2309
2 ZEPOSIA (ozanimod) Hard capsules for oral use. UK SmPC.
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