September 30, 2009

EMD Serono announced this week that it has filed a new drug application with the FDA to allow oral cladribine to be marketed for treating MS. This application is based on results from the CLARITY study, which were presented at this year's AAN and ECTRIMS conferences. The company had submitted a similar application to the European agency EMEA in July of this year. Now the FDA will get to pore over the data and make its decision about whether cladribine will be the first oral drug approved for MS in the US.

Another company with an oral drug candidate, Novartis, released initial results from its two-year placebo-controlled FREEDOMS trial of FTY720 (fingolimod) in relapsing-remitting MS. The drug successfully met the study endpoints including reduction in relapse rate, disability progression, and MRI lesions. Compared with placebo, the two doses of FTY720 used reduced relapse rates by 54-60% and disability progression by 30-32%. The FREEDOMS trial did not identify any new safety concerns and no cases of macular edema or melanoma that had been seen in previous trials were detected. Results from the TRANSFORMS study that compared FTY720 to interferon-beta were reported earlier this year. Novartis says that it plans to file new drug applications with both the FDA and EMEA before the end of the year. So it may be that people with MS will have two oral drugs among their therapy choices next year!

Finally, earlier this week Merck reported that it was ending its phase II trial of atacicept, an injectable drug that affects B cell development. An independent data monitoring committee tasked with reviewing trial data on an ongoing basis reported that the subjects receiving atacicept were having more relapses and new MRI lesions than those on the placebo. This is a good example of the importance of these independent boards for the protection of the health and safety of the people who volunteer for clinical trials.