MS pills are making news.The FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. has granted fast-track status for one MS pill; encouraging data on two others were presented at an international meeting on MS. Oral cladribine In September, Serono, which last year launched a phase 3 trial for oral cladribine, announced that the drug had been designated a "fast-track product" by the U.S. Food and Drug Administration. Oral cladfibine is currently being studied in a multicenter, multinational phase 3 study, CLARITY. This two-year, double-blind, placebo-controlled clinical trial will involve more than 1,200 people with relapsing forms of the disease. Fast-track programs are designed to speed up the review of new drugs that demonstrate the potential to address unmet medical needs. Fingolimod New data from an extension phase after an initial six-month phase 2 trial of fingolimod showed that 77% of people who chose to keep taking the pill once a day remained free from MS relapses over a two year period. Fingolimod also reduced the amount of MS inflammation in the brain as seen on MRI 1. (application) MRI - Magnetic Resonance Imaging. 2. MRI - Measurement Requirements and Interface. . These results were presented at the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS ECTRIMS European Committee for Treatment and Research in Multiple Sclerosis ) meeting in Madrid in September 2006. Novartis AG Novartis AG Swiss pharmaceutical company. It was formed through the 1996 merger of two Swiss firms: Ciba (see Ciba-Geigy) and Sandoz, a chemical company with interests in pharmaceuticals, nutrition, and agriculture. , which manufactures fingolimod, has just launched a two-year phase 3 clinical trial phase 3 clinical trial Phase 3 study. See Phase study. , FREEDOMS. This randomized ran·dom·ize tr.v. ran·dom·ized, ran·dom·iz·ing, ran·dom·iz·es To make random in arrangement, especially in order to control the variables in an experiment. , double-blind, placebo-controlled trial will study 2,000 people worldwide with relapsing-remitting MS. See: dinicaltrials.gov/ ct/show/NCTO0340834. BG00012 shows promise Biogen Idec Biogen Idec, Inc. (NASDAQ: BIIB) is a biotechnology company specializing in drugs for neurological disorders, autoimmune disorders and cancer. The company was formed in 2003 by the merger of Cambridge, Massachusetts-based Biogen and San Diego, California-based Idec presented encouraging data at ECTRIMS from a phase 2 trial of an oral drug called BG00012. The six-month study involving 257 people with relapsing-remitting MS showed that people taking a high dose of BG00012 had a 69% reduction in MS inflammation as seen on MRI scans. A phase 3 trial is expected in the near future. "The recent news on these drugs is encouraging," said John Richert, MD, executive vice president for Research and Clinical Programs for the Society. "But, assuming that data from future trials are positive, it will most likely still be several more years before an oral MS drug is available." |
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