Merck’s Mavenclad has bagged approval in the European Union, Norway, Liechtenstein and Iceland to treat highly active relapsing multiple sclerosis.
Mavenclad (cladribine) 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, annualised relapse rate and magnetic resonance imaging (MRI) activity, according to the firm.
In patients with high disease activity, post hoc analyses of the two-year Phase III CLARITY trial 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.
On the safety side, the most clinically relevant adverse reactions were lymphopenia and herpes zoster.
“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.
“Mavenclad is a selective immune reconstitution therapy (SIRT) which 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.”