Cladribine update - European Commission Grants Approval for Mavenclad (Cladribine Tablets)

New treatment option for relapsing remitting MS

  • First oral short-course treatment for highly active relapsing multiple sclerosis (RMS) now approved in Europe 
  • Mavenclad has shown sustained clinical efficacy for up to four years with a maximum of 20 days of oral treatment

Pharmaceutical company Merck have today announced that the European Commission (EC) has granted marketing authorization for MAVENCLAD® 10mg (Cladribine Tablets) for the treatment of highly active relapsing multiple sclerosis in the 28 countries of the European Union (EU) in addition to Norway, Liechtenstein and Iceland. MAVENCLAD® is the first oral short-course treatment to provide efficacy across key measures of disease activity in patients with highly active RMS, including disability progression, annualized relapse rate and magnetic resonance imaging (MRI) activity. 

MAVENCLAD®’s marketing authorization is based on more than 10,000 patient years of data with over 2,700 patients included in the clinical trial program. The efficacy and safety results of these studies allowed for a full characterization of the benefit-to-risk profile of MAVENCLAD® and up to 10 years of observation in some patients. The clinical development program included data from three Phase III trials, CLARITY, CLARITY EXTENSION5 and ORACLE MS, the Phase II ONWARD study; and long-term follow-up data from the eight-year prospective registry, PREMIERE.  

In patients with high disease activity, post hoc analyses of the two-year Phase III CLARITY trial demonstrated that MAVENCLAD® reduced the annualized relapse rate by 67% and the risk of six-month confirmed EDSS progression by 82% versus placebo. As demonstrated in the Phase III CLARITY EXTENSION5 study, no further MAVENCLAD® treatment was required in Years 3 and 4. The most clinically relevant adverse reactions were lymphopenia and herpes zoster. Lymphocyte counts must be assessed before, and during, treatment with MAVENCLAD®. MAVENCLAD® is contraindicated in certain groups including immunocompromised patients and pregnant women.

Now that MAVENCLAD® 10mg (Cladribine Tablets) has received a license for Europe, the National Centre for Pharmacoeconomics in Ireland (NCPE) will conduct an assessment and make a recommendation as to whether the HSE should reimburse it or not. MS Ireland will be making a Patient Group Submission to the NCPE as part of this process. We will keep all our members and stakeholders updated on any developments regarding the availability of Cladribine in Ireland.

You can read the full press release from Merck here.

You can read more about the process for how medications are licensed and reimbursed in Ireland here.

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