As expected, a Food and Drug Administration advisory panel unanimously recommended approval of Johnson & Johnson's drug-eluting stent, albeit with certain conditions, including more studies. Analysts consider the decision a win that should assure that J&J's Cypher is the first drug-eluting stent on the market. It was disclosed at the hearing that the FDA had sent J&J a deficiency letter on Sept. 18 questioning some of its data. J&J responded on Oct. 21, too close to the panel meeting for an FDA review, according to analysts from UBS Warburg. None of the questions or conditions should delay approval of the product, the analysts said. The FDA typically abides by its advisers' recommendations. Coated with an organ transplant drug called sirolimus, the Cypher likely will cost about three times as much as its bare-metal counterpart but promises to reduce scar-tissue formation, which often necessitates repeat procedures. Drug-eluting stents are the subject of this week's Modern Healthcare cover story. To read the story, click here or go to www.modernhealthcare.com and click on the magazine cover under Current Issue. -- by Cinda Becker
FDA panel backs J&J's drug-coated stent
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