Cladribine Gets a Green Signal from Australian Therapeutic Goods Administration

Russia is reportedly the first country ever to get the licence for the treatment of oral MS treatment using cladribine tablets. This license had been granted to Russia in July 2010. The second on the list is Australia, who has approved the treatment of relapsing remitting MS with the help of cladribine.

Awaiting a decision by the end of this year, the manufacturers, Merck Serono are said to have submitted the drug to the European Medicines Agency for the purpose of licensing in July 2009.

Though the drug, Cladribine has already been licensed as a treatment for leukemia, which is administered by intravenous infusion, yet the National Institute for Health and Clinical Excellence (NICE) is said to have drawn up a draft scope for the appraisal of the drug.

Cladribine is said to bring about a considerable drop in the relapse rates in people with relapsing remitting MS, as per the results put forth, after a two-year study of an oral formulation in relapsing remitting MS.

Movectro (cladribine) has received a green signal from the Australian Therapeutic Goods Administration and the Company says that “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”.