This article was originally published in Pharmaceutical Approvals Monthly
Executive SummaryAmendment to Genentech/Novartis' Xolair (omalizumab) BLA will be submitted by year-end, with an expected six-month review from FDA, Genentech tells analysts. The amendment will include data from the firms' 1,900-patient safety study, ALTO, bringing the total safety database to over 4,000 patients. FDA had deemed the size of the Xolair safety database inadequate and requested platelet monitoring safety data from ALTO, as well as data on subgroups and pharmacokinetics. The BLA, submitted in June 2000 for moderate to severe allergic asthma in adults and adolescents, received a "complete response" letter in July 200
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