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GSK’s Promacta deadline also expires

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

GlaxoSmithKline's PDUFA date also came and went Sept. 19 for Promacta, though not because of strained resources; the missed deadline for eltrombopag is presumably because FDA and GSK are fine-tuning a Risk Evaluation and Mitigation Strategy for the novel drug candidate to treat chronic immune thrombocytopenic purpura (1"The Pink Sheet" DAILY, Sept. 22, 2008). Amgen's NPlate, also indicated for thrombocytopenia, had a similar delay while the REMS was finalized. Analysts said that the missed user fee date was good news for GSK because if the agency had serious concerns it most likely would have issued a complete response letter and not delayed a decision. In May, Promacta received a positive review from the Oncologic Drugs Advisory Committee as a second-line, short-term treatment for ITP, but the panel had reservations about whether the drug would be used for longer term off-label
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