Argentina Approves Mavenclad for Active Relapsing MS

Argentina has become the first country in Latin America to approve Mavenclad (cladribine) as a treatment for adults with highly active relapsing multiple sclerosis.

The Argentinian Administration of Medicines, Food and Medical Technology’s approval covered Merck’s cladribine tablet formulation.

Merck expects to make the treatment available in the country in the next few months.

Mavenclad has already been approved in Canada, Australia, Israel, and Europe. Merck is seeking approval in the United States and other countries.

“Having a new MS treatment approved in Argentina is very motivating,” Dr. Jorge Correale of the Institute for Neurological Research Dr. Raúl Carrea said in a press release.

“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,” said Correale, head of the institute’s neuroimmunology and demyelinating diseases department.

Mavenclad is designed to target the immune T- and B-cells that trigger relapsing MS without suppressing the entire immune system. With a maximum of 20 days’ treatment over two years, the oral drug promotes long-term inhibition of harmful immune cells, reconstituting the immune system. MS is an autoimmune disease, or one in which the immune system attacks normal tissue as well as invadors.

Argentine regulators based their approval on the results of five clinical trials. These were the Phase 3 CLARITY (NCT00213135), CLARITY EXTENSION (NCT00641537), and ORACLE-MS (NCT00725985) studies, the Phase 2 ONWARD study (NCT00436826), and the long-term PREMIERE (NCT01013350) study. These trials involved more than 2,700 patients with relapsing MS, some of whom researchers followed for more than 10 years.

The trials showed that Mavenclad can significantly reduce MS relapse rates, disability progression and brain atrophy.

The treatment is recommended for patients who fail to respond adequately, or are unable to tolerate, other therapies.

“We are pleased the Argentinian Administration of Medicines, Food and Medical Technology has approved Mavenclad,” said Rehan Verjee, the chief marketing and strategy officer of Merck’s biopharma business. “Our goal is to ensure fast access to patients who may benefit from this innovative therapy, and we will be working with payers on obtaining reimbursement as a next step.”