pharmatimesSeptember 22, 2017
Merck’s Mavenclad is now available in the UK and Ireland to treat highly active relapsing multiple sclerosis in adults.
The firm said the drug is the first oral short-course treatment to provide efficacy across key measures of disease activity in adult patients with highly active RMS, including disability progression, annualised relapse rate and magnetic resonance imaging activity, and has the lowest treatment and monitoring burden of all available disease-modifying treatments (DMTs) for the condition.
Mavenclad (cladribine) was approved by European regulators back in August based in part on data from the Phase III CLARITY trial, which showed that the drug cut the annualised relapse rate by 67 percent and the risk of six-month confirmed EDSS (expanded disability status scale) progression by 82 percent versus placebo.
Also, as demonstrated in the Phase III CLARITY EXTENSION study, no further treatment with Mavenclad was required in Years 3 and 4, the firm noted.
Gavin Giovannoni, Professor of Neurology at Barts and The London School of Medicine and Dentistry, Queen Mary University of London, said the availability of Mavenclad "will change the way we treat MS."
The drug is a selective immune reconstitution therapy (SIRT) which simplifies treatment administration, with patients needing 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," he noted, adding: "The not so obvious advantage of Mavenclad is its impact on MS services, for example its ease of use, reduced cost of infusions and monitoring, will liberate staff time to focus on delivering other NHS services".
Merck said it is now in discussions with the relevant reimbursement authorities across the UK and Ireland with the aim of securing funding for the drug.
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