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1、FDA Media Briefing on Plavix 3/12/10 Page 1 Transcript FDA Media Teleconference on Plavix March 12, 2010 Coordinator: Good afternoon, everyone and thank you for standing by. At this time all participants are in a listen-only mode. Throughout the presentation well stop for questions and to ask a ques
2、tion please press star 1. Todays conference call is being recorded and if you have any objections you may disconnect at this time. I would now like to turn the call over to your speaker, Miss Sandy Walsh. You may begin, maam. Sandy Walsh: Thank you. This is Sandy Walsh from the FDAs Office of Public
3、 Affairs. Thank you for joining us today for this briefing. After a brief opening statement we will be taking questions from credentialed reporters only. Id like to introduce Mary Ross Southworth, who is the Deputy Director for Safety with the FDAs Division of Cardiovascular and Renal Products in th
4、e Center for Drug Evaluation and Research. Mary will be discussing a new drug safety - the new drug safety information for the drug Plavix. We are also joined here by other FDA experts. During the question-and-answer session others may comment and will announce their names as they speak. Some of you
5、 have already seen that today we issued a drug safety communication about Plavix. That document is available on the drugs part of our Web site on fda.gov. As well were issuing a press release. FDA Media Briefing on Plavix 3/12/10 Page 2 Im going to ask Mary to go ahead and explain a little bit about
6、 todays action and about the label update and then well take questions. Mary? Mary Ross Southworth: Hi. Good afternoon. Today the FDA approved a new label for Plavix that includes a boxed warning about its diminished effectiveness in patients who can not convert or metabolize Plavix into its active
7、form. Because the patient makes less of the active form there is less anti-platelet effect in the blood and the patient may not receive the full benefit of Plavix treatment. These patients that can not effectively convert Plavix are called poor metabolizers. Information about poor metabolizers and d
8、iminished effectiveness was first included in the Plavix label in May 2009. At that time the Plavix label was updated to show how genetic differences in the functioning of a liver enzyme called CYP2C19 affects drug levels, anti-platelet effects and clinical outcomes. Since that label was approved fu
9、rther evidence has accumulated to support evidence of an association between CYP2C19 type, Plavix exposure and poor treatment outcomes. The most recently approved label, the one that was approved today include information about a sponsor run study that revealed significantly diminished Plavix drug l
10、evels and anti-platelet effects in the group of patients called poor metabolizers, compared to other metabolizer types. In addition the label recommends that prescribers consider alternative anti-platelet therapy or Plavix dosing strategies in patients who are identified as CYP2C19 metabolizers. And
11、 I will open it up for questions now. Sandy Walsh: Operator, were ready to take questions. And if we could please have reporters announce their name and organization. FDA Media Briefing on Plavix 3/12/10 Page 3 Coordinator: Thank you. If youd like to ask a question at this time please press star 1 o
12、n your touchtone phone. To withdraw your question please press star 2. And we will begin with the first question. Its Daniel DeNoon from WebMD. Your line is open. Daniel DeNoon: Thank you for taking my questions. I have a couple. One is - my most pressing one is can you - do you have any sense of ho
13、w many people in generally and specifically how many people on Plavix or what percentage of patients are poor responders. I see estimates ranging from five to 45%. And also is increasing the dose or genetic testing the recommended route to go for patients considering - consider genetic - consider ta
14、king Plavix then might find themselves to be poor metabolizers. Mary Ross Southworth: As far as your first question the frequency of poor metabolizers varies depending on racial background. It occurs in about 2% of Caucasians, 4% of blacks and 14% of Chinese. And then the second question was whether
15、 genetic testing would be recommended and alternate dosing strategies. Is that correct? Daniel DeNoon: Yes it is. Mary Ross Southworth: There are tests that are available to test for CYP2C19 function and to identify poor metabolizers. The recent data that was submitted by the company did give us som
16、e information about what happens in poor metabolizers when you give them increased doses and thats one of the alternative therapies that were - that is recommend in the new box warning. Daniel DeNoon: Do you have any sense of the cost and the availability of this genetic testing? FDA Media Briefing on Plavix 3/12/10 Page 4 Sandy Walsh: Were going to ask Dr. Courtney Harper from the Center for Devices to jump in and answer that one. Courtney Harper: Yes. This is Courtney
