7 December 2017 - First treatment in relapsing-remitting multiple sclerosis to show sustained clinical efficacy for up to 4 years with a maximum of 20 days of oral treatment over 2 years.
Merck today announced that the TGA has updated the registration including the indication, dosing and safety information of Mavenclad (cladribine tablets) for the treatment of relapsing-remitting multiple sclerosis in Australia. As a result, Mavenclad is now approved for the treatment of relapsing-remitting multiple sclerosis to reduce the frequency of clinical relapses and to delay the progression of physical disability.
Following completion of 2 courses of treatment, no further treatment is required in years 3 and 4. The changes bring the Product Information in line with the latest clinical trial evidence supporting Mavenclad.