- First multiple sclerosis (MS) therapy to achieve positive NICE recommendation in the shortest possible timeframe
- Mavenclad has shown sustained clinical efficacy up to four years with a maximum of 20 days of oral treatment over two years
** defined as 1 relapse in the previous year and MRI evidence of disease activity.About MAVENCLAD ® In August 2017, the European Commission (EC) granted marketing authorization for MAVENCLAD ® (Cladribine Tablets) for the treatment of relapsing forms of multiple sclerosis (RMS) in the 28 countries of the European Union (EU) in addition to Norway, Liechtenstein and Iceland. MAVENCLAD ® is a short-course oral therapy that selectively and periodically targets lymphocytes thought to be integral to the pathological process of relapsing MS (RMS). MAVENCLAD ® is currently under clinical investigation and not yet approved for the treatment for any use in the United States or Canada. The clinical development program for MAVENCLAD ® includes:
- The CLARITY (Cladribine Tablets Treating MS Orally) study: a two-year Phase III placebo-controlled study designed to evaluate the efficacy and safety of MAVENCLAD ® as a monotherapy in patients with RRMS.
- The CLARITY extension study: a two-year Phase III placebo-controlled study following on from the CLARITY study, designed to evaluate the safety and efficacy of MAVENCLAD ® over an extended administration for four years.
- The ORACLE MS (Oral Cladribine in Early MS) study: a two-year Phase III placebo-controlled study designed to evaluate the efficacy and safety of MAVENCLAD ®as a monotherapy in patients at risk of developing MS (patients who have experienced a first clinical event suggestive of MS).
- The ONWARD (Oral Cladribine Added ON To Interferon beta-1a in Patients With Active Relapsing Disease) study: a Phase II placebo-controlled study designed primarily to evaluate the safety and tolerability of adding MAVENCLAD ® treatment to patients with relapsing forms of MS, who have experienced breakthrough disease while on established interferon-beta therapy.
- PREMIERE (Prospective Observational Long-term Safety Registry of Multiple Sclerosis Patients Who Have Participated in Cladribine Clinical Studies) study: interim long-term follow-up data from the prospective registry, PREMIERE, to evaluate the safety and efficacy of MAVENCLAD ®
EU Indication MAVENCLAD ® (cladribine tablets) is indicated for the treatment of adult patients with highly active relapsing multiple sclerosis (RMS) as defined by clinical or imaging features.Important EU Safety Information Contraindications: MAVENCLAD ® is contraindicated in patients with hypersensitivity to the active substance, human immunodeficiency virus (HIV), active chronic infection (tuberculosis or hepatitis), active malignancy, moderate to severe renal impairment (creatinine clearance <60 mL/min), and those who are pregnant and breast-feeding. MAVENCLAD ® is also contraindicated in immunocompromised patients, including patients currently receiving immunosuppressive or myelosuppressive therapy. Special warnings and precautions for use: The most clinically relevant adverse reactions were lymphopenia and herpes zoster. Haematology Decreases in neutrophil count, red blood cell count, haematocrit, haemoglobin or platelet count compared to baseline values have been observed in clinical studies, although these parameters usually remain within normal limits. Additive haematological adverse reactions may be expected if cladribine is administered prior to or concomitantly with other substances that affect the haematological profile Lymphocyte counts must be determined
- before initiating MAVENCLAD ® in year 1,
- before initiating MAVENCLAD ® in year 2,
- 2 and 6 months after start of treatment in each treatment year. If the lymphocyte count is below 500 cells/mm³, it should be actively monitored until values increase again.
In the clinical study data base of cladribine in MS (1,976 patients, 8,650 patient years) no case of PML has been reported. However, a baseline magnetic resonance imaging (MRI) should be performed before initiating MAVENCLAD ® (usually within 3 months).About Multiple Sclerosis Multiple sclerosis (MS) is a chronic, inflammatory condition of the central nervous system and is the most common, non-traumatic, disabling neurological disease in young adults. It is estimated that approximately 2.3 million people have MS worldwide. While symptoms can vary, the most common symptoms of MS include blurred vision, numbness or tingling in the limbs and problems with strength and coordination. The relapsing forms of MS are the most common. All Merck Press Releases are distributed by e-mail at the same time they become available on the Merck Website. Please go to http://www.merckgroup.com/subscribeto register online, change your selection or discontinue this service. About Merck Merck is a leading science and technology company in healthcare, life science and performance materials. Around 50,000 employees work to further develop technologies that improve and enhance life - from biopharmaceutical therapies to treat cancer or multiple sclerosis, cutting-edge systems for scientific research and production, to liquid crystals for smartphones and LCD televisions. In 2016, Merck generated sales of € 15.0 billion in 66 countries. Founded in 1668, Merck is the world's oldest pharmaceutical and chemical company. The founding family remains the majority owner of the publicly listed corporate group. Merck holds the global rights to the Merck name and brand. The only exceptions are the United States and Canada, where the company operates as EMD Serono, MilliporeSigma and EMD Performance Materials. References: 1. National Institute for Health and Clinical Excellence (NICE). Final Appraisal Determination Cladribine Tablets for treating relapsing-remitting multiple sclerosis. 2017. Available at: https://www.nice.org.uk/ [ https://www.nice.org.uk/guidance/gid-tag392/documents/final-appraisal-determination-document ] 2. MAVENCLAD® Summary of Product Characteristics. August 2017. Available at: https://www.medicines.org.uk/ [ https://www.medicines.org.uk/emc/medicine/34044.2017] Contact: Erin-Marie Beals, +49-151-1454-2694 (Logo: http://mma.prnewswire.com/media/472778/Merck_Logo.jpg ) SOURCE Merck