Cladribine tablets approved in Australia

The Australian Therapeutic Goods Administration (TGA) has approved Merck’s Cladribine tablets for the treatment of relapsing-remitting multiple sclerosis (MS). Cladribine tablets will be registered in Australia under the trade name Movectro.

“Approval of Cladribine tablets in Australia is another step forward in our commitment to fight the devastating disease of multiple sclerosis by providing new therapeutic options meeting unmet needs,” said Elmar Schnee, member of the executive board and head of the Merck Serono division. “Australia is the second country to approve Cladribine tablets and we will continue our efforts to gain approval of Cladribine tablets in other countries so that more patients can benefit from this oral disease-modifying therapy.”

Cladribine tablets, also under the trade name Movectro, became the first oral MS treatment in the world to gain marketing authorization when health authorities in Russia approved it in July 2010. Merck Serono initiated global submissions for Cladribine tablets in mid-2009 and to date has submitted regulatory applications for Cladribine tablets covering about 40 countries.

The oral formulation of cladribine is an investigational treatment for patients with relapsing forms of MS. Cladribine is a small molecule that may interfere with the behavior and the proliferation of certain white blood cells, particularly lymphocytes, which are thought to be involved in the pathological process of MS.

MS is a chronic, inflammatory condition of the central nervous system and is the most common, non-traumatic, disabling neurological disease in young adults. It is estimated that approximately two million people have MS worldwide. While symptoms can vary, the most common symptoms of MS include blurred vision, numbness or tingling in the limbs and problems with strength and coordination. The relapsing forms of MS are the most common.