Cladribine

Parent company: EMD Serono, Inc.

• This drug is given orally once or twice a year, depending on the study regimen. It is currently used in an injectible form to treat leukemia.


• Based on studies of injectible cladribine showing an average 90-percent reduction in gadolinium-enhancing lesions and a marked reduction in relapse rate, the orally administered form was designated by the FDA as a Fast Track product for relapsing forms of MS, for potentially quick approval. It may be approved by the FDA within a year.


• This drug causes a preferential and sustained depletion of specific classes of T cells in the immune system. It also seems to directly influence the overall T-cell response.


• The two-year Phase III CLARITY trial of two levels of cladribine versus placebo met its primary end point, showing 55 to 58-percent reductions in annualized relapse rates. In the ongoing two-year extension study, all participants will receive cladribine.


• The ONWARD Phase II study of 200 individuals who have experienced at least one relapse while taking Rebif is now recruiting. This study combines oral cladribine with Rebif.


• The Phase III ORACLE MS study will assess the safety and efficacy of two doses of oral cladribine versus placebo in individuals who have had a CIS. The study is currently recruiting participants.