Petaling Jaya, 3 May 2021 – Merck Sdn Bhd has launched MAVENCLAD® (cladribine), a short-course oral therapy now approved in Malaysia for the treatment of adult patients with relapsing forms of multiple sclerosis. Clinical data indicates that MAVENCLAD® has four years of efficacy with a maximum of 20 days oral treatment over two years1-4.
Multiple sclerosis (MS) is an immune mediated disorder and chronic disease of the central nervous system which damages the brain’s ability to perform fundamental functions. It is a rare disease affecting 2.8 million people worldwide as at 20205. Multiple sclerosis has an estimated prevalence of two to three per 100,000 population in Malaysia.6 While it is an uncommon disease, there is clearly an unmet need to improve the diagnosis, treatment and management for adult patients with relapsing multiple sclerosis, seeing how the disease impacts patients at the prime of their lives.
Understanding Multiple Sclerosis
According to Dr Shanthi Viswanathan, Consultant Neurologist at Hospital Kuala Lumpur, multiple sclerosis is often diagnosed between the ages of 20 and 406 and is the leading cause of non-traumatic disability in young adults.7 This debilitating disease is five times more common in women than in men6 and usually strikes at a time when young women are still studying, entering the workforce or just starting a family. It disrupts their personal and professional lives.
“Multiple sclerosis is not curable, and the goal of the treatment is to accelerate the patient’s recovery and prevent further progression. The disease is highly unpredictable, and rarely two patients’ symptoms are alike. Those with severe multiple sclerosis may progress rapidly to irreversible or total disability,” said Dr Shanthi.
Of the four types of multiple sclerosis, Dr Shanthi shared that the most common type is relapsing-remitting multiple sclerosis (RMS), affecting 85% of all patients.8 People with RMS suffer episodic acute worsening (relapses) of neurological symptoms, followed by temporary remissions. An episode can last for hours or days, and the recovery process would take a couple of weeks or months, depending on the symptoms.
Among the symptoms of multiple sclerosis are fatigue, numbness and tingling, muscle spasm, stiffness and weakness, mobility issues, vision impairment, speech difficulties, vertigo, pain especially in the back, bladder or bowel problems and difficulty in swallowing.
Dr Shanthi advised, “I have witnessed people with symptoms of multiple sclerosis but unknowingly equate the symptoms with other common diseases. My advice is to seek help from health care practitioners like physicians and neurologists when having symptoms suggestive of multiple sclerosis in order to properly clarify the diagnosis and rule other neuro-immunological conditions that may mimic multiple sclerosis. Get the right diagnosis and opt for early treatment to manage the condition and symptoms.”
Hope for Relapsing MS Patients in Malaysia
MAVENCLAD® is a short-course oral therapy for relapsing forms of multiple sclerosis. It targets the B and T lymphocytes (major cellular components of the adaptive immune response) with minimal impact on innate immune function.
Taken orally for a maximum of 10 days in years 1 and 2, followed by observation in Years 3 and 4, MAVENCLAD® is shown to deliver four years of efficacy with a maximum of 20 days oral dosing over two years1-4.
MAVENCLAD® has a tailored weight-based dosing regimen. Administered in two courses, one at the beginning of the first month and one at the beginning of the second month of the respective treatment year, to a total of 3.5 mg per kg of body weight over two years, followed by no further active treatment with MAVENCLAD® in Years 3 and 4.1
Clinical Data on MAVENCLAD®
MAVENCLAD® is supported by over 14 years of clinical trial and post-approval experience in multiple sclerosis. The clinical development program of MAVENCLAD in MS comprises more than 12,000 patient years of data with over 2,700 patients included in the clinical trial program, and up to 10 years of observation in some patients. These clinical trials include the Phase III CLARITY, CLARITY extension and ORACLE MS trials, the Phase II ONWARD trial and the PREMIERE Long-term Safety Registry. 2-4,13-14
In the clinical trials, 1,976 patients received therapy for a total of 9,855 patient years.
MAVENCLAD® demonstrated clinical efficacy across key measures of disease activity, such as annualised relapse rate, disability progression, and magnetic resonance imaging (MRI) activity:
- Patients experienced a 58% relative reduction in the annualised relapse rate with MAVENCLAD® compared to placebo. 2
- 79.7% of patients were free of relapses after two years of treatment with MAVENCLAD®, compared to 60.9% of patients who received placebo. 2
- Patients treated with MAVENCLAD® had a 47% reduction in risk of 6-month confirmed disability progression as compared to placebo.11
- Patients taking MAVENCLAD® experienced lower brain lesions compared to patients with placebo. 2,12
MAVENCLAD® has a well-characterized safety and tolerability profile with up to 10 years of safety follow-up in some patients. 2,4,13-14
Public Awareness of Multiple Sclerosis
“The introduction of MAVENCLAD® addresses specific areas of unmet medical needs for multiple sclerosis. It offers a new and innovative way to treat relapsing multiple sclerosis with our short course oral therapy. At Merck, we are also focused on educating Malaysians that improved multiple sclerosis care means early access to both early diagnosis and treatments with high levels of efficacy and safety, especially for relapsing multiple sclerosis. Our aim is to delay disease and symptom progression, help prevent relapses and prolong the effectiveness of treatment in the long term. We seek to improve patients’ quality of life and empower them to go about daily living with greater ease,” said Dr Amit Singh, Medical Director, Merck Biopharma (Malaysia, Singapore and Brunei).
With more than 20 years of experience in the area of multiple sclerosis, Merck has a proud history of delivering innovative solutions in advancing multiple sclerosis care. As at March 2019, MAVENCLAD® has been approved in 53 countries worldwide since 2017 and is now launched in Malaysia.
For more information about multiple sclerosis and MAVENCLAD®, please consult your healthcare professional.
