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Postive Data for Abbott’s Proposed Heart Stent
The data continue to be favorable for Abbott Laboratories’ new drug-coated heart stent, Xience V, a device for which the company hopes to win federal approval.
The newest data, released today by the company and federal regulators, showed that Xience outperformed Boston Scientific’s Taxus 2, the market leader, in preventing coronary arteries from reclogging over a two-year period in more than 600 patients.
There was no difference between Xience and Taxus in terms of deaths or heart attack rates. But the newer stent’s advantage over Taxus in protecting against reclogging led to fewer repeat procedures to keep patients’ arteries open.
That confirmed earlier results, covering shorter periods, which have raised confidence on Wall Street that a federal advisory panel, meeting Thursday, will recommend that the Food and Drug Administration approve Xience. Analysts predict that Xience will quickly become a best seller if the F.D.A. allows it to enter the market. Abbott Laboratories’ shares closed up more than 3 percent, at $55.91.
Analysts have estimated that Xience could claim up to 55 percent of what is forecast as a $1.8 billion annual market in the United States for drug-coated stents over the next few years. That would include Xience sales under a different name — the Promus stent — which would be marketed in an arrangement with Boston Scientific.
Stents are small metal mesh cylinders inserted into coronary arteries after blockages have been cleared to keep them propped open. Since 2003, the market has been dominated by drug-coated devices because they do a better job of preventing reclogging than the bare-metal stents that preceded them.
But sales and use have fallen in the last 18 months on safety concerns and the belief among some cardiologists that many patients who have been getting stents to relieve chest pain can fare just as well by relying on drugs and lifestyle changes like quitting smoking.
The only two drug-coated devices currently approved for the United States are the Taxus and Johnson & Johnson’s Cypher stent. Medtronic is expected to gain approval for its drug-coated Endeavor stent as early as the end of December, and Wall Street has anticipated that Xience could reach the market by next summer.
Wall Street’s biggest concern has been that the advisory panel that meets on Thursday might recommend that Abbott be required to submit more long-term safety data than it has accumulated, which could delay approval.
Based in part on experience on Europe, where all four stents and several others are on the market and prices have fallen below $1,000 for drug-coated devices, some health care providers are hoping the new devices will lead not only to improved outcomes for patients but also a price war. The average price for the devices in the United States is currently more than $2,000.
Endeavor and Xience both use drugs that are chemical relatives of the immune-system suppressant used on Cypher. Xience’s drug, evirolimus, is licensed from Novartis, and that company’s safety data is part of the package it presented to federal regulators for Thursday’s meeting.
The F.D.A. staff review of the data to be presented Thursday noted that there was too little long-term evidence to reach any conclusions about the likelihood that clots could form in Xience stents long after they were implanted. Such clotting, a rare but potentially fatal problem, has been linked to drug-coated stents now on the market.
http://www.nytimes.com/2007/11/2 ... ent.html?ref=health |
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发表于 2007-12-4 10:52:14