Merck asserts the ANMAT’S approval for MAVENCLAD tablets for treating multiple sclerosis
Leading Science and technology company, Merck announced that the Argentinian Administration of Medicines, Food and Medical Technology has sanctioned the registration of MAVENCLAD (cladribine tablets) for the treatment of adult patients with highly active relapsing multiple sclerosis (MS) as defined by clinical or imaging features.
This allegedly marks the first approval for MAVENCLAD in Latin Amercia and the product is expected to be available in the coming months.
Dr. Jorge Correale M.D., the Head of Neuroimmunology and Demyelinating Diseases at the Institute for Neurological Research Dr. Raúl Carrea. said “Mavenclad allows the patient’s immune system to go through a selective immune reconstitution, similar to a reset, and the treatment mechanism is simple because it does not require frequent administration or monitoring.”
MAVENCLAD is the first oral short-course treatment to provide efficacy across key measures of disease activity in patients with highly active relapsing MS, including disability progression, annualized relapse rate and magnetic resonance imaging (MRI) activity. The approval of MAVENCLAD is based on more than 10,000 patient years of data with over 2,700 patients included in the clinical trial program, and up to 10 years of observation in some patients. The clinical development program included data from three Phase III trials, CLARITY, CLARITY EXTENSION and ORACLE MS,the Phase II ONWARD study; and long-term follow-up data from the 8-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 6-month confirmed expanded disability status scale (EDSS) progression by 82% versus placebo. As demonstrated in the Phase III CLARITY EXTENSION study, no further MAVENCLAD treatment was required in Years 3 and 4. The comprehensive dataset has informed the posology and monitoring requirements.
The approval for MAVENCLAD in Argentina follows marketing authorizations in the EU, Canada, Australia and Israel. Merck plans additional filings for regulatory approval in other countries, including the United States.