Score one for Abbott Laboratories. An FDA advisory panel gave its backing to the company's new Xience stent, albeit an endorsement tinged with caution. The committee said Xience should be cleared for sale on one condition--that Abbott conduct post-marketing research on the product.
The agency doesn't always take its advisor panels' advice, of course. And the request for a post-marketing trial might delay Abbott's planned 2008 launch. But the group agreed that the drug-coated stent is effective, and likely more effective than currently marketed models. They also liked the safety data; they just wanted more of it, especially more long-term data.
The panel might have been extra-cautious because of the still-simmering debate over the safety of drug-coated stents. Worries about the risk of complications, especially clotting, have markedly slowed sales of the products, which can be up to three times as expensive as bare-metal stents.
- see the release [1]
- check out this report [2] from the Chicago Tribune
Related Articles:
J&J sues Abbott to block new stent. Report [3]
FDA panel to review Abbot's coated stent. Report [4]
Study: Coated stents aren't cost-effective. Report [5]
Links:
[1] http://www.fiercebiotech.com/press-releases/boston-scientific-welcomes-fda-panel-recommendation-approve-promus-tm-xience-tm-v-eve
[2] http://www.chicagotribune.com/business/chi-fri_stent1130nov30,0,7894265.story
[3] http://www.fiercepharma.com/story/j-j-sues-abbott-block-new-stent/2007-11-29
[4] http://www.fiercepharma.com/story/fda-panel-review-abbots-coated-stent/2007-11-07
[5] http://www.fiercepharma.com/story/study-coated-stents-aren-t-cost-effective/2007-11-02?utm_medium=nl&utm_source=link