Nplate Déjà Vu: FDA Delays GSK’s Promacta PDUFA Date
This article was originally published in The Pink Sheet Daily
Executive Summary
Fears over long-term use led to three-month postponement.
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FDA's decision to extend the PDUFA date for GlaxoSmithKline's thrombopoietin receptor agonist Promacta by three months doesn't surprise analysts, given the agency's previously stated concerns about risk management. The PDUFA date for once-daily Promacta (eltrombopag), partnered with Ligand Pharmaceuticals, has been shifted to September 19 from June 19. "This really is not a major shocker," Derek Jellinek, Susquehanna analyst, told "The Pink Sheet" DAILY. The British drugmaker had submitted an application for the oral drug in second-line treatment of chronic idiopathic thrombocytopenic purpura to increase platelet counts and reduce or prevent bleeding in December. Amgen's Nplate (romiplostim), another stalled thrombocytopenia drug, had also stirred risk management concerns (1 (Also see "FDA Delays Action On Amgen’s Nplate" - Pink Sheet, 8 Apr, 2008.)). At the end of May, a panel of FDA's Oncologics Advisory Committee voted unanimously in favor of Promacta for short-term treatment but questioned whether GSK would be able to limit off-label, long-term use (2 (Also see "ODAC Unanimously Recommends GSK’s Promacta For ITP" - Pink Sheet, 30 May, 2008.)). Writing in a research note at the time, Jellinek and colleague Andrew Peters observed that the June PDUFA date was not "set in stone," and any delay "would likely depend on GSK's capability to quickly augment its risk management plan to sufficiently answer many of the agency's outstanding safety concerns, including weekly monitoring of liver enzyme levels and bone marrow biopsy for many patients." Thousand Oaks, Calif.-based Amgen also needed to come up with a solid risk-management program after a unanimously favorable committee vote and its decision date was set back to July 23 from April 23. The Promacta delay is a negative in that it extends timetables, but the drug should win approval in September, Jellinek told the DAILY. -Emily Hayes ([email protected]) |