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Executive Summary

BERLEX' BETASERON IS APPROVABLE FOR MULTIPLE SCLEROSIS, receiving the designation from FDA during the week of May 25. Betaseron (interferon beta) will be the first product specifically approved for treatment of MS; it is also the first biologic to be designated as "approvable" during the application review process. The PLA (92-0495) revie for Betaseron was conducted under an intercenter agreement between the Center for Drug Evaluation and Research and the Center for Biologics Evaluation and Research. FDA and Berlex are understood to still be working on the labeling for the interferon product. Issues that may be under discussion include conditions for self-administration of Betaseron. During the clinical trials reported with the PLA, patients self-administered the injectable subcutaneously on alternate days for two years. The approvable status for Betaseron comes two months after the drug was recommended for approval in the reduction of neurological exacerbations in patients with relapsing-remitting multiple sclerosis by FDA's Peripheral & Central Nervous System Drugs Advisory Committee ("The Pink Sheet" March 22, p. 5). The committee found Betaseron effective in decreasing vision problems and improving motor coordination or tremors in people with MS. In the single Phase III multicenter trial of the interferon product on 338 MS patients, the every-other-day dosage Betaseron 45 mil. IU produced a 34% reduction in the rate of exacerbations compared to placebo. Betaseron also increased the time to first exacerbatio by 93%. Lesion area measured by MRI increased by 19.4% in the placebo group while it decreased by 4.2% in the Betaseron- treated patients.

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