Novartis receives European and UK licence for Kesimpta® ▼ (ofatumumab), the first self-administered B-cell therapy for patients with relapsing forms of MS

• Ofatumumab is a self-administered targeted B-cell depleting treatment option for adult patients living with relapsing forms of multiple sclerosis (RMS) with active disease, defined by clinical or imaging features^1,2

• Self-administration at home, with initial guidance from a healthcare professional, gives RMS patients flexibility and reduces the burden on patients, healthcare professionals and the NHS, as it faces capacity challenges in light of COVID-19³

• The licence is based on two Phase III ASCLEPIOS studies that met primary endpoints, demonstrating a significant reduction in the number of relapses vs teriflunomide, evaluated as the annualized relapse rate (ARR)¹

• Ofatumumab is one of the first treatments to undergo the new regulatory process by the Medicines and Healthcare products Regulatory Agency (MHRA) obtaining marketing authorisation in Great Britain

London, 07 April 2021 — Novartis today announced that the Medicines and Healthcare products Regulatory Agency (MHRA), alongside the recent European Commission, has granted a marketing authorisation for the use of ofatumumab for the treatment of adult patients with relapsing forms of multiple sclerosis (RMS) with active disease, defined by clinical or imaging features². Ofatumumab has the potential to become a recognised treatment option for eligible UK patients with RMS that can be self-administered, with initial guidance from an appropriately trained healthcare professional, once monthly at home via the Sensoready^® autoinjector pen¹.

Ofatumumab is one of the first treatments to undergo the new regulatory process following the UK’s departure from the European Union. The final Marketing Authorisation (MA) from the MHRA, brings eligible patients living with RMS a step closer to access Kesimpta in England, Scotland and Wales. Initial decisions on Kesimpta from the National Institute for Health and Care Excellence (NICE) and the Scottish Medicine Consortium (SMC) are expected to publish their final advice this year.

Relapsing remitting MS (RRMS) is the most common form of the disease, with around 85% of people considered to have RRMS at the point of diagnosis⁴. While there is a range of disease-modifying therapies (DMTs) for RMS, there are significant needs that are still not fully met by current treatment options. A recent survey reported that people with MS are not satisfied with today’s treatments due to a lack of efficacy, safety concerns, or tolerability issues^5,6.

“The MS Trust is delighted that ofatumumab, the first self-administered B-cell therapy for people with relapsing forms of MS with active disease, has been granted both MHRA and EMA licence. Relapsing forms of MS can have a serious and difficult impact on all aspects of people’s lives,” said David Martin, Chief Executive Officer, Multiple Sclerosis Trust. “Ofatumumab can potentially give independence to a group of people who have previously had to rely upon regular medical visits to treat this life-changing condition. We hope ofatumumab will provide people living with relapsing forms of MS a sense of independence, and positively impact their lives by reducing their disease progression.”

“The MS clinical community welcomes today’s news, which provides us with a new treatment option to support a group of patients who, to date, have continued to experience disease activity with this devastating condition,” said Consultant Neurologist, Dr. Owen Pearson at Morriston Hospital, Swansea. “MS is a complex disease, and each individual will respond differently to disease-modifying therapies. The self-administration of ofatumumab benefits both the clinical community and eligible patient community.”

“At Novartis we are proud to be offering innovative treatments that help improve the lives of people living with MS,” said Chinmay Bhatt, Managing Director UK, Ireland & Nordics for Novartis Pharmaceuticals. “Ofatumumab is an innovative treatment for those in the beginning stages of their MS journey. Ofatumumab demonstrates our commitment to reimagining medicine and we will work closely with all UK stakeholders to ensure eligible patients can start benefitting from this treatment as quickly as possible.”

About Kesimpta^® (ofatumumab)
Ofatumumab is a fully human anti-CD20 monoclonal antibody (mAb) self-administered by a once-monthly injection, delivered subcutaneously^1,7. 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^2,8 Ofatumumab allows faster repletion of B cells versus other anti-CD20 monoclonal antibodies and, therefore, may offer flexibility in the management of RMS⁹.

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)¹. 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 5.5¹. The primary endpoint from the ASCLEPIOS I and II studies was the annualized relapse rate (ARR), defined as the number of confirmed MS relapses per year, up to the end of the trial¹. Overall across both studies, 946 patients were assigned to receive ofatumumab and 936 teriflunomide, resulting in ofatumumab demonstrating a significant reduction in annualized 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; primary endpoint)^1,10. 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 infections¹.

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 condition¹¹. 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 loss¹². 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)¹³. There are three types of MS: relapsing-remitting MS (RRMS), secondary progressive MS (SPMS) and primary progressive MS (PPMS)¹⁴. Patients with relapsing forms of MS – including RRMS and SPMS with active disease – experience distinct attacks of symptoms, known as relapses^4,15. Around 85% of people are considered to have RRMS at their point of diagnosis¹⁶. 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)^15,17.

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 forms of MS. 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 relapsing-remitting MS (RRMS), 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. Find out more at www.novartis.co.uk.

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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