Taxus expedited review change-of-heart
This article was originally published in The Gray Sheet
Executive Summary
FDA grants "fast-track" review status to Boston Scientific's paclitaxel-eluting stent PMA - a reversal from earlier agency indications. During a January CRT meeting, FDAers claimed expedited review would not be given to a second drug-eluting stent because the device would not address an unmet clinical need (1"The Gray Sheet" Feb. 3, 2003, p. 6). FDA now says it granted Boston Scientific's request because there currently is no approved drug-eluting stent available in the U.S. Johnson & Johnson's Cypher sirolimus stent, the first PMA to be filed with the agency, is widely expected to gain FDA approval the week of March 17. The Taxus reversal also reflects Commissioner Mark McClellan's emphasis on efficient review and prompt designation of innovative technologies...
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Boston Scientific TAXUS V
Paclitaxel-eluting stent clinical trial for 1,100 patients at 70 U.S. centers commences March 18. The study will evaluate the Taxus stent in patients considered to be at higher risk for restenosis than the 1,326 patients treated in TAXUS IV. On the same day, Boston Scientific submitted the second module of the device's PMA; the firm expects to file the fifth and final module in June and hopes for approval by year-end. FDA will prioritize review and approval of Taxus to provide competition for Johnson & Johnson/Cordis's Cypher, which is expected to be approved by the end of March (1"The Gray Sheet" March 17, 2002, In Brief)...
TAXUS Set For April 2004 Approval Based On Tentative Cypher Timeline
Boston Scientific will not be granted expedited review for its Taxus paclitaxel-eluting stent after Johnson & Johnson/Cordis' Cypher sirolimus-eluting stent is approved in the U.S., based on the premise that fast-track PMAs should address an unmet clinical need
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