Merck today announced that Mavenclad® (cladribine 10 mg tablets) has been selected as a Rapid Uptake Product1 by the Accelerated Access Collaborative (AAC). It is one of seven medicinal and medical technology products to be identified as a highly transformative innovation by the AAC, which aims to bring forward patient access to selected, highly beneficial and affordable innovations.2
Commenting on the positive news, Gavin Giovannoni, Professor of Neurology at Barts and The London School of Medicine and Dentistry, Queen Mary University of London said
«The journey that cladribine tablets (Mavenclad) has had to get to people with MS is a truly remarkable story. The fact that it has now been selected as one of the innovations of the accelerated access collaborative initiative is a testament to the perseverance of Merck and the MS community.
Cladribine tablets has many highly attractive attributes, including a novel mode of action, high efficacy and a low treatment and monitoring burden; this, with NHS support to promote wider access and adoption of cladribine tablets could transform the treatment of multiple sclerosis in the UK.»
Cladribine tablets are the first short-course oral treatment available in the UK for adults with highly active relapsing MS, that can help reduce relapses for up to four years with a maximum of 20 days’ oral treatment, taken in the first and second year.3,4 Following completion of treatment in the first two years, no additional treatment is required in years 3 and 4.5
“We are delighted that Mavenclad has, yet again, been recognised as an innovative medicine whichhas the potential to offer benefits to both patients and carers as well as value for money to the NHS,” said Liz Henderson, General Manager of Merck UK & ROI.
She added, “Merck is committed to working in partnership with the AAC to address barriers to uptake and increase system efficiencies to ensure all eligible UK patients can benefit from this innovation.”
Today’s announcement follows a decision by NICE in November 2017 to recommend cladribine tablets for eligible NHS patients – the first MS disease modifying therapy to go straight to a positive recommendation through the NICE appraisal process.6 In addition, Merck and NHS England partnered on a commercial agreement to ensure MS patients in England were amongst the first in the world to access the medicine.
Merck is delighted that cladribine tablets have been selected as a Rapid Uptake Product and look forward to working collaboratively with all stakeholders to ensure patients can benefit from this clinically and cost-effective medicine.
Notes to Editors
About MAVENCLAD (Cladribine 10mg tablets)5
MAVENCLAD® received marketing authorisation from the European Commission in August 2017 for the treatment of highly active relapsing MS in adults in the 28 countries of the European Union in addition to Norway, Liechtenstein and Iceland. It is a short-course oral therapy that selectively and periodically reduces lymphocytes thought to be integral to the pathological process of MS. The approved dose for MAVENCLAD® 10mg tablets is 3.5mg/kg body weight over 2 years administered as 1 treatment course of 1.75 mg/kg per year. Each treatment course consists of 2 treatment weeks, one at the beginning of the first month and one at the beginning of the second month of the respective treatment year. Each treatment week consists of 4 or 5 days on which a patient receives 10 mg or 20 mg (one or two tablets) as a single daily dose, depending on body weight. Following completion of the 2 treatment courses, no further cladribine treatment is required in years 3 and 4.
The clinical development programme 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.4
- The CLARITY extension study: a two-year Phase III placebo-controlled extension study designed to evaluate the Safety and Tolerability of MAVENCLAD® in Subjects With Relapsing-Remitting MS Who Have Completed the CLARITY study. This study also explored clinical benefit of prolonged 4 year versus 2 year treatment.3
- 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).7
- The ONWARD (Oral Cladribine Added ON To Interferon beta-1a in Patients With Active Relapsing Disease) study: a Phase II placebo-controlled study designed to evaluate the safety, tolerability and effectiveness of adding MAVENCLAD® treatment to patients with relapsing forms of MS, who have experienced breakthrough disease while on established interferon-beta therapy.8
- 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 of MAVENCLAD®. The follow-up will consist of over 10,000 patient years of exposure in total, with follow- up in some patients exceeding eight years at completion.9
About Multiple Sclerosis (MS)
Multiple sclerosis (MS) is an autoimmune, chronic and inflammatory condition that affects the central nervous system (CNS) and is the most common, non- traumatic, disabling neurological disease in young adults. Approximately 100,000 people in the UK10 have MS. Relapsing remitting MS (RRMS) where the symptoms appear (relapse) and then disappear (remission), either partially or completely, is the most common form of MS, and around 85% of people initially diagnosed with MS have this type. The exact cause of MS is unknown, but it is thought that the body’s immune system attacks myelin, disrupting the information flow along the nerves. There is currently no cure for MS, but treatments are available to help slow the course of the disease.11
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.
1 Rapid Uptake Products Announcement. Available at: http://www.ahsnnetwork.com/nhs-test-beds-accelerated-access-collaborative/ Last accessed: October 2018
2 Accelerated Access Collaborative Overview. Available at https://www.nice.org.uk/aac. Last accessed: October 2018
3 Giovannoni, G et al. Mult Scler J 2017 doi: 10.1177/1352458517727603. [Epub ahead of print]
4 Giovannoni G, et al., N Engl J Med 2010;362:416-26
5 MAVENCLAD® Summary of Product Characteristics.
6 NICE. Final Appraisal Determination cladribine tablets for treating relapsing- remitting multiple sclerosis. 2017. Available at: https://www.nice.org.uk/guidance/ta493
7 Leist T et al. Lancet Neurol 2014; 13: 257–67
8 Montalban X et al, Neurol Neuroimmunol Neuroinflamm 2018
9 Clinicaltrials.gov, PREMIERE safety registry; Available at: https://clinicaltrials.gov/ct2/show/NCT01013350?term=NCT01013350&rank=1. Last accessed October 2018
10 NHS Choices, Multiple Sclerosis. Available at: http://www.nhs.uk/conditions/Multiple-sclerosis/Pages/Introduction.aspx. Last accessed August 2018
11 Multiple Sclerosis in Adults: Management. NICE. October 2017. Available at: https://www.nice.org.uk/guidance/cg186/chapter/Introduction. Last accessed: October 2018
A Product Manager with expertise in pharma marketing and sales operations