Cladribine granted licence in the UK and Ireland

Cladribine (Mavenclad) has been licensed in the UK and Ireland for the treatment of adult patients with highly active and relapsing multiple sclerosis (MS). This follows a positive decision by the European Commission in August 2017, which recommended cladribine for marketing authorisation.

“This is an exciting moment and one that will change the way we treat MS,” said Gavin Giovannoni, Professor of Neurology at Barts and The London School of Medicine and Dentistry, Queen Mary University of London.

Cladribine is an antimetabolite that targets lymphocytes, which are thought to be key to the pathology of MS, by interfering with the DNA strand and DNA synthesis. The therapy is a short-course oral treatment of two annual courses in four years, with two treatment weeks per month in which a patient receives 10 mg or 20 mg as a single daily dose, depending on body weight, for five consecutive days.

In the phase III CLARITY trial, cladribine tablets were shown to reduce the annualised relapse rate of MS by 67% vs. placebo [HR 0.33 (0.23-0.48), p<0.0001]. However, there was an increased risk in adverse reactions of lymphopenia and herpes zoster, which means that lymphocyte counts must be assessed before, and during, treatment.

Prof Giovannoni said: “[cladribine] simplifies treatment administration, by giving patients just two short annual courses of tablets in four years. Patients can benefit from the treatment over a longer period of time without having to continually take medication and without the need for frequent monitoring.”

An earlier 2010 application for the licence of cladribine was unsuccessful due to the suggestion in the first CLARITY phase III trial that there was an associated cancer risk with the drug. However, the two year follow-up extension study has demonstrated that there is no associated cancer risk.

Following the positive licence decision, the Mavenclad’s producer (Merck) is currently in negotiations to secure funding for cladribine tablets in the UK and Ireland.

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