Approved therapy to treat two types of multiple sclerosis (MS), progressive and relapsing forms of MS, launches in UAE

First and only approved disease-modifying therapy for primary progressive multiple sclerosis (PPMS), one of the most disabling forms of MS[2] [3]

First and only approved MS treatment to target the immune cells, thought to be responsible for the damage that leads to disability[4] 

Dubai: OCREVUS™ (ocrelizumab), a first of its kind therapy for both relapsing (RMS) and primary progressive forms of multiple sclerosis (PPMS), amongst the most disabling forms of MS, is now available in the UAE. Offering renewed hope to patients across the Emirates, the therapy, launched by Roche Pharmaceuticals and approved in August 2017 by the UAE Ministry of Health and Prevention (MOHAP), is the first and only disease-modifying approved therapy available world-wide that targets both forms of PPMS and RMS. OCREVUS™ (ocrelizumab) is also a superior to another therapy, as studies show, it reduced signs of disease activity and slowed the disability progression considerably[5].

MS is a chronic autoimmune disorder for which there is currently no cure[6]. It occurs when the immune system abnormally attacks the protection cover around the nerve cells in the brain, spinal cord and optic nerves, causing inflammation (lesions) and consequent damage to the way nerves work. MS is a lifelong condition, but not a terminal illness[7]. Anyone can develop MS; however, it is more common in people with a family history of it, more prevalent in women than men, and usually diagnosed when people are in their 20s and 30s[8].  

The symptoms resulting from the damage can range from muscle weakness, fatigue, vision loss, bladder incontinence, unsteadiness and difficulty walking, to eventual disability[9] [10] [11]. It is the most common cause of disability in young people globally[12]. There are two forms of the disease, PPMS and relapsing-remitting multiple sclerosis (RMS). Approximately 85 percent of people with MS are initially diagnosed with RMS, while 15 percent are diagnosed with PPMS[13]. RMS, the most common form of MS, is characterised by episodes of new or worsening signs or symptoms (relapses) followed by periods of recovery[14] [15]. PPMS, the more debilitating form of the disease, is marked by steadily worsening symptoms, typically without distinct relapses or periods of remission[16].

“Until now, people affected by PPMS didn’t have any treatment options, which only left patients to hope that the disease wouldn’t aggressively progress. Now, those living with PPMS could hope to enjoy a perceptible improvement in their quality of life, thanks to slower disability progression and reduced signs of damage in the brain,” said Abed Sabra, General Manager, Roche Pharmaceuticals in the UAE.

“While this is a milestone moment for the MS community and Roche, there is still much more to be done to improve the lives of people living with the condition. Increased public awareness around the disease is a must for helping patients come to terms and cope with the disease, and feel better understood and supported,” urged Abed.

A persistent myth about MS is that once diagnosed people should give up work, physical activity, and not have children[17]. However, this is not true: MS is a life-long condition, with which people can still live a full life[18].

Mr Ahmed Al Miskari, who is Head of Patient Affairs at the Multiple Sclerosis Foundation in Al Ain and also suffers from MS, explained: “Very often, individuals with MS suffer from depression, leave their careers, experience emotional stress and become socially withdrawn. These things are avoidable as it’s becoming easier for people with MS to live a full, rewarding and enjoyable life as an active member of the community. I encourage all MS patients to seek support, and also help foster increased public awareness about the disease.”

OCREVUS™ (ocrelizumab) is unique in the way it targets the immune cells, thought to be responsible for the damage (lesions) that lead to disability, while allowing the immune system to continue functioning. It has also been proven to be an important and more effective new treatment option for people with relapsing forms of MS[19]. As shown by studies in patients with RMS, compared with another therapy, it reduced attacks per year by nearly half, more effectively decreased signs of disease activity, and was better at slowing disability progression over the two-year controlled treatment period[20]. Forty percent of patients with RMS were less likely to have disability progression[21]. In patients with PPMS, compared with a placebo, OCREVUS was the first and only treatment to significantly slow disability progression over a median treatment duration of three years[22]. Twenty four percent of people with PPMS were less likely to have disability progression, and 39 percent saw the volume of their lesions (damage in the brain) reduced[23].

His Excellency, Dr. Amin Hussain Al Amiri, Assistant Undersecretary for Medical Practice and License Sector at the Ministry of Health & Prevention (MOHAP) in the UAE, said: “Patients’ welfare is at the heart of our mission, which is why we are welcoming innovations like this into our market, as they make a real difference to patients’ and their family’s lives, health and happiness.”

Data on the number of MS patients in the UAE is unfortunately scarce, outdated, and mostly specific to a limited number of medical facilities[24]. A SEHA study, conducted between 2010 and 2014 in four key public hospitals in Abu Dhabi, found there were 510 people living with MS[25]. However, this number is expected to be higher due to all the unreported cases. The crude prevalence rate of MS in Abu Dhabi is estimated to be 18 people per 100,000[26], whereas in the Emirati population alone it is expected to reach 64 people per 100,000[27].

Dr Ahmed Shatila, Neurology Consultant, Mafraq Hospital in Abu Dhabi, added: “It is wonderful to see such improvements and innovations in the treatment and management of MS. It is crucial of course to raise awareness about the different treatment options patients have, but the most important factor to me is the dialogue between the doctor and the patient. As a doctor, I can’t stress enough to patients how important it is to ask the right questions, not only when first diagnosed but also during the course of their lifetime.”

Dr Shatila suggests the following questions to help patients with MS start the conversation with their doctor around optimising quality of life:

• How frequently does this suggested therapy require monitoring and testing?
• Will this therapy allow me to continue doing the things I am passionate about (i.e. traveling)?
• How much compliance will this therapy need from me? I.e. What happens if I am busy and forget a dose?
• What can I do to improve my quality of life?
• What are things my family can do to help me live a better life?
• What are things I can do to prevent added stress and emotional burden?
• Can I still play sports?
• Is there anything special I should consider with regards to family planning?
• How can I explain my condition in simple terms to my employer and/ or family?

To further raise awareness about the therapy, Roche recently held a workshop in the UAE with healthcare professionals and key stakeholders.

-Ends-

MOHAP approval reference #: GC89348 

For media inquiries, please contact:
Hill+Knowlton Strategies, Alia Karim
056 501 9503, Alia.karim@hkstrategies.com

About OCREVUS (ocrelizumab)

OCREVUS is a humanised monoclonal antibody designed to selectively target CD20-positive B cells, a specific type of immune cell thought to be a key contributor to myelin (nerve cell insulation and support) and axonal (nerve cell) damage. This nerve cell damage can lead to disability in people with MS. Based on preclinical studies, OCREVUS binds to CD20 cell surface proteins expressed on certain B cells, but not on stem cells or plasma cells, and therefore important functions of the immune system may be preserved.

OCREVUS is administered by intravenous infusion every six months. The first dose is given as two 300 mg infusions given two weeks apart. Subsequent doses are given as single 600 mg infusions.

About Roche in neuroscience

Neuroscience is a major focus of research and development at Roche. The company’s goal is to develop treatment options based on the biology of the nervous system to help improve the lives of people with chronic and potentially devastating diseases. Roche has more than a dozen investigational medicines in clinical development for diseases that include multiple sclerosis, Alzheimer’s disease, spinal muscular atrophy, Parkinson’s disease and autism.

About Roche

Roche is a global pioneer in pharmaceuticals and diagnostics focused on advancing science to improve people’s lives. The combined strengths of pharmaceuticals and diagnostics under one roof have made Roche the leader in personalised healthcare – a strategy that aims to fit the right treatment to each patient in the best way possible.

Roche is the world’s largest biotech company, with truly differentiated medicines in oncology, immunology, infectious diseases, ophthalmology and diseases of the central nervous system. Roche is also the world leader in in vitro diagnostics and tissue-based cancer diagnostics, and a frontrunner in diabetes management.

Founded in 1896, Roche continues to search for better ways to prevent, diagnose and treat diseases and make a sustainable contribution to society. The company also aims to improve patient access to medical innovations by working with all relevant stakeholders. Twenty-eight medicines developed by Roche are included in the World Health Organization Model Lists of Essential Medicines, among them life-saving antibiotics, antimalarials and cancer medicines. Roche has been recognised as the Group Leader in sustainability within the Pharmaceuticals, Biotechnology & Life Sciences Industry eight years in a row by the Dow Jones Sustainability Indices (DJSI).

The Roche Group, headquartered in Basel, Switzerland, is active in over 100 countries and in 2016 employed more than 94,000 people worldwide. In 2016, Roche invested CHF 9.9 billion in R&D and posted sales of CHF 50.6 billion. Genentech, in the United States, is a wholly owned member of the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, Japan. For more information, please visit www.roche.com.

[1] OCREVUS (ocrelizumab) Prescribing Information. Genentech, Inc. 2016.

[2] OCREVUS (ocrelizumab) Prescribing Information. Genentech, Inc. 2016.

[3] National Multiple Sclerosis Society. Treating PPMS. Available at http://www.nationalmssociety.org/What-is-MS/Types-of-MS/Primary-progressive-MS/Treating-Primary-Progressive-MS.

[4] OCREVUS (ocrelizumab) Prescribing Information. Genentech, Inc. 2016.

[5] OCREVUS (ocrelizumab) Prescribing Information. Genentech, Inc. 2016.

[6] National Institutes of Health-National Institute of Neurological Disorders and Stroke. Multiple Sclerosis: Hope Through Research. Available at: https://www.ninds.nih.gov/Disorders/Patient-Caregiver-Education/Hope-Through-Research/Multiple-Sclerosis-Hope-Through-Research.

[7] Multiple Sclerosis Trust, Facts and Myths about MS. www.mstrust.org.uk/understanding-ms/what-is-ms/facts-and-myths-about-ms.

[8] Multiple Sclerosis Trust, Facts and Myths about MS. www.mstrust.org.uk/understanding-ms/what-is-ms/facts-and-myths-about-ms.

[9] Ziemssen T. (2005). Modulating processes within the central nervous system is central to therapeutic control of multiple sclerosis. J Neurol, 252(Suppl 5), v38-v45.

[10] Hauser S.L. et al. (2012). Multiple sclerosis and other demyelinating diseases. In Harrison’s Principles of Internal Medicine (pp.3395-3409). New York, NY: McGraw Hill Medical.

[11] Hadjimichael O. et al. (2007). Persistent pain and uncomfortable sensations in persons with multiple sclerosis. Pain, 127(1-2):35-41.

[12] Multiple Sclerosis International Federation. What is MS? Available at http://www.msif.org/about-ms/what-is-ms/.

[13] National Multiple Sclerosis Society. Types of MS. Available at http://www.nationalmssociety.org/What-is-MS/Types-of-MS.

[14] Lublin F.D., Reingold S.C. (1996) Defining the clinical course of multiple sclerosis: results of an international survey. National Multiple Sclerosis Society (USA) Advisory Committee on Clinical Trials of New Agents in Multiple Sclerosis. Neurology, 46(4):907–11.

[15] Lublin F.D. et al. (2014). Defining the clinical course of multiple sclerosis. Neurology, 83(3):278-86.

[16] Multiple Sclerosis International Federation. Types of MS. Available at https://www.msif.org/about-ms/types-of-ms/.

[17] Multiple Sclerosis Trust, Facts and Myths about MS. www.mstrust.org.uk/understanding-ms/what-is-ms/facts-and-myths-about-ms.

[18] Multiple Sclerosis Trust, Facts and Myths about MS. www.mstrust.org.uk/understanding-ms/what-is-ms/facts-and-myths-about-ms.

[19] New England Journal of Medicine. (2017). 376(3): 209-234. Available at: http://www.nejm.org/toc/nejm/376/3.

[20] New England Journal of Medicine. (2017). 376(3): 209-234. Available at: http://www.nejm.org/toc/nejm/376/3.

[21] OCREVUS (ocrelizumab) Prescribing Information. Genentech, Inc. 2016.

[22] New England Journal of Medicine. (2017). 376(3): 209-234. Available at: http://www.nejm.org/toc/nejm/376/3.

[23] OCREVUS (ocrelizumab) Prescribing Information. Genentech, Inc. 2016.

[24] Schiess, N., et al., How global MS prevalence is changing: A retrospective chart review in the United Arab Emirates. Multiple Sclerosis and Related Disorders(2016), http://dx.doi.org/10.1016/j.msard.2016.07.005i

[25] Abu Dhabi Health Services Company (SEHA). (accessed113.12.15).

[26] Schiess, N., et al., How global MS prevalence is changing: A retrospective chart review in the United Arab Emirates. Multiple Sclerosis and Related Disorders(2016), http://dx.doi.org/10.1016/j.msard.2016.07.005i

[27] Schiess, N., et al., How global MS prevalence is changing: A retrospective chart review in the United Arab Emirates. Multiple Sclerosis and Related Disorders(2016), http://dx.doi.org/10.1016/j.msard.2016.07.005i

© Press Release 2018