Merck Serono's oral MS drug cladribine gets second approval, in Australia

The Australian Therapeutic Goods Administration (TGA) has approved German drug major Merck KGaA (FWB: MRK) subsidiary Merck Serono's cladribine tablets for the treatment of relapsing-remitting multiple sclerosis (MS). Cladribine tablets will be registered in Australia under the trade name Movectro. The drug is already marketed as a cancer treatment.

"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, president of Merck Serono. "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," he added.

Also under the trade name Movectro, cladribine became the first oral MS treatment in the world to gain marketing authorization when health authorities in Russia approved it a few weeks back (The Pharma Letter July 12). 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 German drugmaker has recently re-filed for clearance with the US Food and Drug Administration, which had previously issued a complete response notification that delayed the approval process (The Pharma Letter June 8).