BRIEF—Australia approves Mavenclad for relapsing-remitting multiple sclerosis

7 December 2017

Germany’s Merck KGaA has received approval from Australia’s medicines regulator for Mavenclad (cladribine), for the treatment of relapsing-remitting multiple sclerosis.

Yesterday the company announced the short-course oral therapy had been approved in Canada in the same indication. Approval was granted in Europe in August.

Merck has yet to receive approval for the drug in the USA, after the FDA rejected the firm’s registration application in 2011, calling for more safety data. The company says it will now reapply.

Consultant neurologist Bill Carroll said: "Mavenclad will be a welcomed treatment option for patients with the relapsing-remitting form of MS.”

“As an oral therapy taken in two short courses over a two-year period, Mavenclad will be convenient for all eligible patients in Australia, including those who may not live close to their treating healthcare professional."

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