BRIEF—Multiple sclerosis therapy Mavenclad given green light in Canada

Merck KGaA’s American biotech subsidiary EMD Serono has announced that the Candian medicines regulator Health Canada has approved Mavenclad (cladribine tablets) for certain multiple sclerosis patients.

The oral therapy was approved as a second-line monotherapy for the relapsing-remitting form of the disease.

The decision was based on safety and efficacy data from the Phase III CLARITY study.

Mavenclad was approved in Europe in August, but has not been approved in the USA. In 2011 the US FDA rejected the firm’s registration application, calling for more safety data. Merck says it will now reapply for approval there.