First approval in Latin America for Mavenclad

Argentinian Administration of Medicines, Food and Medical Technology (ANMAT), has approved 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 marks the first approval for Mavenclad in Latin America and following local regulatory processes, the product is expected to be available in the coming months, said German pharma and chemicals major Merck KGaA (MRK: DE), which came close to abandoning development of oral cladribine back in 2011.

The drug was approved in Europe in August last year, and in Australia and Canada in December last year. Merck plans additional filings for regulatory approval in other countries, including the USA.