The Scottish Medicines Consortium recommends Novartis’ Kesimpta®▼ (ofatumumab) for patients living with relapsing remitting multiple sclerosis (RRMS)

The Scottish Medicines Consortium recommends Novartis’ Kesimpta^®▼ (ofatumumab) for patients living with relapsing remitting multiple sclerosis (RRMS)

·      Novartis’ Kesimpta^® (ofatumumab) is the first at-home self-administered B-cell therapy recommended by the Scottish Medicines Consortium (SMC) for adult patients with relapsing remitting multiple sclerosis (RRMS) with active disease defined by clinical or imaging features ¹

·      Scotland has the highest average prevalence rate of MS in the UK. Amongst the MS Scottish population this rate is higher in women than men, and is more prevalent to those living in the north of the country ^2,3

·      SMC approval is based on pivotal trial data that showed ofatumumab reduced relapses by more than half in patients with RMS (relapsing forms of MS) – the most common form of the disease – when compared with another disease modifying therapy, teriflunomide⁴

·      A high efficacy treatment that offers self-administration at home, with initial guidance from a healthcare professional, gives people with RRMS more flexibility versus other treatments and reduces the burden on patients, healthcare professionals and the NHS which is facing capacity challenges in light of COVID-19⁵

London, UK, 12 July 2021 – Novartis today announced that eligible patients in Scotland will soon have access to Kesimpta^® (ofatumumab), the first self-administered, targeted B-cell therapy for patients with relapsing remitting multiple sclerosis (RRMS) with active disease defined by clinical or imaging features. The news comes as the Scottish Medicines Consortium (SMC) published their final advice recommending ofatumumab for the treatment of RRMS with active disease defined by clinical or imaging features¹.

Scotland has the highest average prevalence rate of MS in the UK, with about 15,750 people estimated to be living with the disease^2,3. Rates are significantly higher amongst women than men, and further to this MS is more prevalent to those living in the north of the country².

Patients with RRMS in Scotland have previously been unable to access a high efficacy, B-cell therapy through the NHS without regular visits to a clinic or hospital for treatment. For patients in the far north of the country where MS is most prevalent, that could have meant a long journey to the nearest specialist centre in Inverness⁶.

Ofatumumab, designed to be self-injected once a month using the Sensoready^® autoinjector pen, uses specially engineered antibodies that target a subset of the body’s B-cells, a type of immune cell that abnormally damages nerves in the brain and spinal cord in patients with MS^7,8. In clinical trials, ofatumumab delivered on the primary endpoint significantly reducing relapses by more than 50% when compared to teriflunomide (a commonly prescribed oral disease modifying therapy for RRMS)⁴.

The SMC concluded that ‘Ofatumumab has the potential to reduce relapse rates, slow disease progression and improve quality of life.’ It went on to say, ‘while some people with MS may need help from a carer or family member for administration, self-injection once a month is likely to be straightforward and will minimise the treatment burden for many people. Taking medication at home also minimises any delay in starting treatment and reduces the need for regular hospital visits¹.’

“It is welcome news that we will soon have access to a convenient, new medicine for the treatment of relapsing remitting multiple sclerosis in Scotland”, said Dr Javier Carod Artal, consultant neurologist at Raigmore hospital, NHS Highlands, Inverness. “As the first targeted B-cell therapy that can be taken at home, ofatumumab provides a much-needed high-efficacy treatment option that clinicians can prescribe from diagnosis onwards, even to patients who can’t travel for regular hospital visits for treatment.”

Research published by the MS Society in June 2020 found that during the first wave of the pandemic, one in four MS patients surveyed in the UK said they had appointments delayed or cancelled, and a further 6% said they cancelled their appointments for fear of infection⁹.

“People living with MS need to have access to a range of different treatment options so they can work with their healthcare team to find the one that’s best for them. But, the ability to administer yourself once a month will be a game changer”, said Iain Morrison, Chief Executive, Revive MS Support. “Many people living with MS in Scotland live in very rural areas a long way from specialist MS care, and despite widespread vaccination some still tell us they are worried about catching COVID-19 if they travel to visit them.”

The SMC’s decision follows a similar recommendation from NICE earlier this year. The Final Appraisal Document (FAD) from NICE was published in April unusually quickly, just two weeks after the Medicines and Healthcare products Regulatory Agency (MHRA) granted Marketing Authorisation, recognising the value ofatumumab brings to patients and the NHS10,11. The SMC’s decision today means that eligible patients in Scotland can soon access ofatumumab.

“Innovating to solve complex challenges is at the heart of Novartis. In Scotland, where many people with MS live a long way from specialist care, ofatumumab provides an opportunity for them to access a highly effective treatment that can be self-administered at home. This is especially important whilst COVID-19 is still front of mind for many patients as well as for the NHS”, said Chinmay Bhatt, Managing Director UK, Ireland & Nordics for Novartis Pharmaceuticals. “We are proud to help improve access to medicines for patients no matter where they live in the UK, and continue to build on our heritage to reimagine medicines for all.”

About Kesimpta^® (ofatumumab)

Ofatumumab is a fully human anti-CD20 monoclonal antibody (mAb) licensed for adults with relapsing forms of multiple sclerosis (RMS) with active disease defined by clinical or imaging features, which is intended to be self-administered by a once monthly injection, delivered subcutaneously^4,11. As shown in preclinical studies, ofatumumab is thought to work by binding to a distinct epitope on the CD20 molecule, inducing potent B-cell lysis and depletion^11,12. Ofatumumab allows faster repletion of B-cells upon discontinuation versus other anti-CD20 mAbs, and therefore may offer flexibility in the management of RRMS¹³.

About ASCLEPIOS I and II studies

The ASCLEPIOS I and II studies are twin, identical design, flexible duration (up to 30 months), double-blind, randomised, multicentre, Phase III trials evaluating the safety and efficacy of ofatumumab versus teriflunomide in adults with relapsing forms of multiple sclerosis (RMS)⁴. The studies were conducted in 37 countries and enrolled 1,882 patients between the ages of 18 and 55 years, with an Expanded Disability Status Scale (EDSS) score between 0 and 5.5⁴. The primary endpoint from the ASCLEPIOS I and II studies was the annualised relapse rate (ARR), defined as the number of confirmed MS relapses per year, up to the end of the trial⁴.

Overall across both studies, 946 patients were assigned to receive ofatumumab and 936 teriflunomide, resulting in ofatumumab demonstrating a significant reduction in annualised relapse rate (ARR) by 50.5% (0.11 vs 0.22) and 58.5% (0.10 vs 0.25) compared with teriflunomide in ASCLEPIOS I and II, respectively (p<0.001 in both studies)^4,14. Ofatumumab also showed a relative reduction in three- and six- month confirmed disability worsening (CDW) compared to teriflunomide: 34.4% (p=0.002) in three-month CDW (10.9% for ofatumumab and 15.0% for teriflunomide) and 32.5% (p=0.01) in six-month CDW (8.1% for ofatumumab and 12% for teriflunomide)⁴. In addition, results demonstrated a significant relative reduction in the mean number of both Gd+ T1 lesions (97.5% (0.01 vs 0.45) and 93.8% (0.03 vs 0.51), respectively, both p<0.001) and new or enlarging T2 lesions (82% (0.72 vs 4.00) and 84.5% (0.64 vs 4.15) versus teriflunomide, respectively, both p<0.001⁾⁴. The most important and frequently reported adverse events for ofatumumab are upper respiratory tract infections, systemic injection-related reactions, injection-site reactions, and urinary tract infections⁴.

About multiple sclerosis (MS)

There are approximately 130,000 people with MS in the UK, and each year around 7,000 people are newly diagnosed with the condition15. MS is a chronic disorder of the central nervous system (CNS) that disrupts the normal functioning of the brain, optic nerves and spinal cord through inflammation and tissue loss¹⁶. The evolution of MS results in an increasing loss of both physical and cognitive functions (e.g. mobility problems, numbness, bladder and bowel problems, and problems with thinking, learning, and planning)¹⁷. There are three types of MS: relapsing-remitting MS (RRMS), secondary progressive MS (SPMS) and primary progressive MS (PPMS)¹⁸. Patients with relapsing forms of MS (RMS) – including RRMS and SPMS with active disease – experience distinct attacks of symptoms, known as relapses^19,20. Around 85% of people are considered to have RRMS at their point of diagnosis²⁰. SPMS, which typically follows from an initial RRMS course, is characterised by a gradual worsening of neurological function over time and can be described as active (with relapses and/or evidence of new magnetic resonance imaging [MRI] activity) or not active (no evidence of current activity)^19,21.

About Novartis in multiple sclerosis (MS)

Novartis has a strong ongoing commitment to neuroscience and to bringing innovative treatments to patients suffering from neurological conditions where there is a high unmet need. The Novartis MS portfolio includes Gilenya^®▼ (fingolimod, an S1P modulator), which is licensed in the UK and Europe for the treatment of adults and children aged 10 years and older with highly active relapsing-remitting MS (RRMS). Mayzent^®▼ (siponimod) is licensed in the UK and Europe for the treatment of adult patients with secondary progressive MS (SPMS) with active disease evidenced by relapses or imaging features of inflammatory activity. Extavia^® (interferon beta-1b for subcutaneous injection) is licensed in the UK and Europe to treat people with RRMS (≥2 relapses in the last 24 months), people with SPMS with active disease (evidenced by relapses) and people who have had a single clinical event suggestive of MS with an active inflammatory process.

About Novartis

Novartis is reimagining medicine to improve and extend people’s lives. As a leading global medicines company, we use innovative science and digital technologies to create transformative treatments in areas of great medical need. In our quest to find new medicines, we consistently rank among the world’s top companies investing in research and development. Novartis products reach more than 800 million people globally and we are finding innovative ways to expand access to our latest treatments. About 130,000 people of nearly 150 nationalities work at Novartis around the world.

In the UK, we employ approximately 1,500 people to serve healthcare needs across the whole of the UK, as well as supporting the global operations of Novartis. Since 2014, Novartis has invested over £200 million in R&D and is a leading sponsor of clinical trials, in the UK. For more information, please visit www.novartis.co.uk.

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