Oral cladribine moves one step closer to European approval as an MS therapy

The pharmaceutical company Merck KGaA has submitted an application to the European Medicines Agency (EMEA) (the European Union's FDA) asking them to approve oral cladribine as a therapy for patients with relapsing-remitting multiple sclerosis. Similar applications to the FDA and other countries' agencies will be following soon. The company hopes to be able to market this drug in 2010, which might make it the first oral drug officially authorized as a disease-modifying therapy in MS.

Cladribine is a chemotherapy drug that depletes white blood cells and is used to treat certain forms of leukemia. Recent results from the Phase III CLARITY trial showed that it reduced relapse rate and MRI disease activity in people with RRMS. The treatment schedule used in the trial involved taking the drug only 2 to 4 weeks per year. This drug would be easier to take than the current first-line therapies for MS, but would perhaps come with a greater risk of complications due to its strong effects on the immune system.

[Thanks for Stephanie S. for the pointer to this story!]