Just wondering if anyone read this.......From NMSS??
Jun 15, 2010
FDA Agrees to Fast Track Status for Drug Being Tested for MS
It was announced by the drug maker Genzyme Corporation (Cambridge, MA) that intravenous alemtuzumab has been designated by the U.S. Food and Drug Administration as a “Fast Track Product.” This designation should expedite its future review by the FDA after the sponsor submits results of current phase 3 trials that are underway (these studies have completed enrollment but are not yet completed).
Multiple sclerosis occurs when the immune system mistakenly attacks the brain and spinal cord. Alemtuzumab is a humanized monoclonal antibody directed at CD52 (a protein on the surface of immune cells) that is currently approved by the FDA as a single agent for treatment of patients with B-cell chronic lymphocytic leukemia. Its ability to target immune cells led to its testing as a possible treatment for relapsing-remitting MS.
Earlier Phase 2 studies showed that treatment with alemtuzumab reduced the accumulation of disability and the frequency of relapses in people with early relapsing-remitting MS, compared to Rebif® (interferon-beta-1a-rebif/index.aspx, interferon beta-1a, EMD Serono, Inc. and Pfizer, Inc.). (New England Journal of Medicine 2008 359;17:30-45)
Rebif is a registered trademark of EMD Serono, Inc. and Pfizer, Inc.
http://www.nationalmssociety.org/news/news-detail/index.aspx?nid=3356
Take Care,
~Tonya