In Phase III trials 865 patients located in 13 countries outside the United States were given different doses of Benlysta (belimumab), or a placebo, for a one-year period. Of patients receiving the placebo 44 percent experienced meaningful improvement in their symptoms whereas 58 percent of those having high dose Benlysta saw improvement and 52 percent having low dose improved. Benlysta is given intravenously in one-hour outpatient sessions, once a month otherwise the digestive tract breaks it down. Human Genome has obtained an agreement with the FDA on the study"s design so it meets regulatory requirements for a new drug application to get its approval. Analysts cited data in earlier clinical trials including a history of failures for treatments of lupus and do not expect positive results. If findings from a second phase 3 trial due in November are favorable, Human Genome Sciences and GlaxoSmithKline, which are sharing rights to the drug, will apply for regulatory approval.
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