nani
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Joined: 09 Oct 2005
Posts: 191
Location: USA- California
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 Posted: Sat Sep 30, 2006 9:27 pm Post subject: FDA Agrees to Fast Review for Pill Being Tested for MS |
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FDA Agrees to Fast Review for Pill Being Tested for MS
-- Company Still Recruiting for Clinical Trial
September 21, 2006
It was announced today by the drug maker Serono (Geneva) that oral cladribine, now being tested in an international Phase 3 clinical trial, 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 and, if the pill proves to be safe and effective, speed the day when there is an oral therapy for treating multiple sclerosis.
Cladribine can interfere with the activity of white blood cells that underlie the immune attacks that cause the unpredictable symptoms of MS. The two-year, placebo-controlled clinical trial of oral cladribine, called the CLARITY study, is still recruiting patients with relapsing-remitting MS in 16 states: CO, GA, IL, IN, MD, MI, NJ, NC, NV, NY, OH, OK, OR, SC, WA, WV. (Information about this trial is available at www.clinicaltrials.gov/show/NCT00213135; for information about participating in this trial, go to www.theclaritystudy.com/nmso.)
-- Research and Clinical Programs
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