The United Arab Emirates is the first country in the Middle East and Africa to approve Mavenclad (cladribine tablets) as a treatment for patients with highly active relapsing multiple sclerosis (MS) evidenced through imaging tests or clinical evaluation.
The therapy is expected to become available once local regulatory processes are complete.
Mavenclad was approved under an accelerated review by the United Arab Emirates (UAE) Ministry of Health and Prevention, its manufacturers, Merck KGaA, announced.
“The accelerated processes … allow for significant advancements in care, and we applaud them for fostering an environment in which patients gain expedited access to innovations such as Mavenclad,” Rehan Verjee, chief marketing and strategy officer at the Biopharma business of Merck, said in a press release. (The German company is known as EMD Serono in North America.)
The therapy is designed to target immune T- and B-cells that trigger relapsing MS without suppressing the entire immune system. With a maximum of 20 days of treatment over two years, the oral drug has shown an ability to help patients remain relapse-free for up to four years while working to “reset” the immune system.
UAE regulators based their approval on the results of five clinical studies: 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) trial. These trials involved more than 2,700 relapsing MS patients, some of whom were followed for more than 10 years.
The trials showed that Mavenclad can significantly reduce annualized MS relapse rates and prevent the risk of disability progression. The treatment was also shown to prevent brain atrophy in these patients.
During the clinical trials, the most clinically relevant adverse reactions reported were reduced levels of lymphocytes (white blood cells), and increased susceptibility to herpes infection. As such, a patient’s lymphocyte levels must be assessed before and during this treatment.
Mavenclad is recommended for patients who fail to respond adequately, or are unable to tolerate, other therapies. It should not be used by patients who have a compromised immune system or by pregnant women.