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REMS Likely Holdup For GSK’s Promacta Approval

This article was originally published in The Pink Sheet Daily

Executive Summary

FDA misses eltrombopag Sept. 19 PDUFA date; analysts draw parallel with Amgen’s Nplate timeline.

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Luitpold Citizen Petition May Handicap AMAG’s Ferumoxytol

A citizen petition filed by AMAG rival Luitpold stressing the dangers of intravenous iron therapy - an area with well-known hazards - seems designed to handicap AMAG's nanoparticle agent ferumoxytol, which bears a PDUFA date of Oct. 19

Luitpold Citizen Petition May Handicap AMAG’s Ferumoxytol

A citizen petition filed by AMAG rival Luitpold stressing the dangers of intravenous iron therapy - an area with well-known hazards - seems designed to handicap AMAG's nanoparticle agent ferumoxytol, which bears a PDUFA date of Oct. 19

GSK’s Promacta deadline also expires

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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