FDA Panel Review Safety Data On The Use of Drug Eluting Stents. A Food and Drug Administration panel is slated to review safety data on the use of Johnson & Johnson (JNJ) and Boston Scientific’s (BSX) drug-eluting stents amid concerns that the devices could lead to greater instances of blood clots.
Specialists on the FDA circulatory system devices panel will meet Thursday and Friday to review safety data, conduct public hearings and determine whether the stent makers will be required to submit additional safety data on their devices.
Some stents, which are used to prop open arteries cleared of plaque, are coated with drugs designed to prevent regrowth of tissue in the area where the device is implanted. But recent studies have found that the polymers that enable the slow release of drugs remain after all active ingredients are absorbed. Scientists worry they could cause a reaction by the immune system, leading to tissue regrowth within the blood vessel.
At the meeting, panelists are expected to discuss whether FDA approvals or recommendations for stent use should be changed based on how severe a patient’s condition is, whether the patient is diabetic or otherwise belongs to a high-risk group, according to briefing documents posted on the agency’s Web site.
The panel is also expected to discuss how long patients should take blood thinners like Bristol-Myers Squibb (BMY) and Sanofi-Aventis’ (SNY) blockbuster drug Plavix after stents are implanted, another measure that doctors use to prevent artery re-clogging.
“The panel could take some steps toward quantifying what the problem may or may not be and possible solutions,” says Steve Brozak, health care analyst at investment research firm WBB Securities. On whether drug companies could benefit from greater use of their treatments as stent use potentially declines, he says, “This could be a game where you see a decline but you don’t see someone else benefiting from the decline.”
Drug-Eluting Stents Increased Rate Of Death
In order to determine what measures to take on stents, the FDA panel will consider data, and possibly request more, on whether the use of drug-eluting stents is associated with an increased rate of death compared with stents made of bare metal.
Another concern, which could have a short-term impact on the companies’ stocks, is the question of whether safety concerns apply to both Johnson & Johnson’s Cypher stent and Boston Scientific’s Taxus. The companies are fierce competitors for stent market share and are in constant battle with data supporting that each company’s stent is superior to the other’s.
For example, study results presented at the Transcatheter Cardiovascular Therapuetics conference in October showed that, after a year, J&J’s stent was associated with a 0.6% risk of artery reclogging compared with no risk for bare-metal stents, and Boston’s device led to a so-called late-stent-thrombosis rate of 0.7% vs. 0.2% in bare-metal stents.
But regardless of which stent is shown to cause more of a risk of reclogging, and even if the FDA panel recommends the equivalent of a black box warning about the device’s safety, “it’s not so much what the panel is going to do. It’s what the payers and managed care companies are going to do” in response to the meeting’s outcome, says Les Funtleyder, health care analyst at institutional trading firm Miller Tabak. The FDA issues black box warnings when studies show that a drug carries a significant risk of serious, possibly life-threatening, side effects.
Funtleyder says managed care companies will take a closer look at data, specifically the health risk tradeoff between drug-coated and bare stents, to determine whether to change authorization requirements for use of the devices. The analyst expects to see decreased use of drug-eluting stents in favor of the bare devices, and notes that both companies’ DES sales have already lost out to bare-metal stents by a few percentage points of market share.
At the panel meeting, “there will be a lot of rhetoric from people who believe they’re more dangerous, which may weigh on the stocks,” Funtleyder says. But he believes that for the most part, safety concerns are already priced in.
The meeting could remove some uncertainty surrounding the safety concerns, and eventually lead to a response from the FDA and managed care companies’ responses, but ultimately, “getting it over with will be helpful to the stocks and the whole medical device group,” the analyst says. “I don’t see much of a negative coming out of the meeting, and in the absence of a negative, I suppose it would be a positive.”