Cladribine Tablets: FDA says not yet

The CLARITY study demonstrated that oral cladridine reduced multiple sclerosis relapses by 58% as well as reduced the likelihood of disability progression and new MRI activity.  While the FDA concluded that there was substantial evidence of cladribine’s effectiveness,  additional information was requested by the FDA regarding improved understanding of the safety risks.  Ongoing trials may help clarify the potential risks including ONWARD, a trial of adding cladribine to interferon,  and ORACLE, a trial of starting cladribine after a first attack.  ONWARD results will be available in the first half of 2012 and ORACLE results will be available by the end of 2011.  The MS  Center for Innovations in Care has been a trial site for the ONWARD trial.