Neurology Central

Multiple sclerosis drug trials: Luciano Rossetti on the recent cladribine approval

This month saw the European Commission approve cladribine 10 mg tablets (MAVENCLAD®) for the treatment of highly active relapsing multiple sclerosis (MS). In this interview, we speak to Luciano Rossetti, Global Head of R&D at Merck, who discusses the recent approval, as well as the current MS drug pipeline.

What are the current unmet needs for patients with MS?

MS is associated with a substantial clinical and economic burden on patients, caregivers and healthcare systems, and is more pronounced in patients with high disease activity.

Although many treatments for MS already exist, they generally involve continuous suppression of the immune system, which can lead to side effects such as increased risk of infections and malignancy. They can also involve a substantial treatment administration and monitoring burden, and both of these factors can lead to frequent treatment switches and the associated disruption for the patient.

How could cladribine address these needs? What are the benefits of this new treatment option?

MAVENCLAD® is the first oral, short-course treatment for highly active relapsing multiple sclerosis (RMS) to deliver 4 years of disease control with a maximum of 20 days of oral treatment. It is thought to do this by selectively and periodically targeting lymphocytes thought to be integral to the pathological process for MS.

The dosing regimen for MAVENCLAD® involves a maximum of 20 days of oral treatment across 2 years, meaning patients can benefit from the treatment over a period of 4 years without having to continually take medication and attend frequent monitoring.

What do you anticipate the next steps will be? How soon could patients have access to these tablets?

MAVENCLAD® is now approved for the treatment of highly active RMS in over 30 countries across Europe. It is expected to become commercially available to patients in Europe by prescription within the coming months, with launches in Germany and the UK expected as early as September 2017.

MAVENCLAD® regulatory submissions are also currently being initiated in other global markets.

What are Merck’s current projects and priorities in the MS space?

With more than 20 years of experience in MS, Merck has a proud history of delivering innovative solutions in advancing MS care and is committed to driving research and development to address specific areas of unmet need.

We are committed to continuing to build on existing data supporting cladribine tablets for patients with MS, alongside our well-established treatment Rebif.

We are also working on a global MS care partners survey that is helping us to identify new ways to support MS patients, their friends and families. The survey is being launched in response to preliminary findings from research commissioned by Merck, which indicate that while 18–34 year-olds make up the largest group of MS care partners, the impact of caregiving during the prime of their lives and the challenges faced by this group are poorly understood. The global survey aims to provide a deep understanding of these unmet needs as a first step towards developing better resources and solutions for MS care partners in the future.

Update (9th November 2017):

  • NHS England partners with Merck on a commercial agreement that allows people with MS in England immediate access to cladribine tablets
  • The NHS England agreement was announced by Simon Stevens at today during his keynote speech at the FT Global Pharmaceutical and Biotechnology conference in London, UK
  • NICE has also recommended use of Merck’s MS therapy cladribine tablets for highly active disease in adults