Fw: Egrifta Teleconference

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Sent via BlackBerry by AT&TFrom: "Klein, M" <.Klein@...>Date: Wed, 1 Dec 2010 16:53:33 -0500Klein, M<.Klein@...>Subject: Egrifta TeleconferenceGood afternoon, In preparation for the Egrifta call tomorrow, I am providing the time and call-in information, the approved product label, and additional additional information about the clinical studies, safety issues, and post-marketing requirements that will be discussed. The call will take place on Thursday, December 2, 2010 at 2 PM EST.Dial in number: 888-566-7608 Passcode: EGRIFTAFor those unable to join the call, or others who you think might be interested in the content, Replay will be available, generally available one hour after a call ends, and will remain available until JAN-02-11 11:00 PM (ET)Phone: 800-337-6572Best,_____________________________________________ Dear Colleague:I know that you have long been interested and involved in issues surrounding HIV-associated lipodystrophy.As you know, on November 10, 2010, FDA approved Egrifta (tesamorelin) to induce and maintain a reduction of excess visceral abdominal fat in HIV-infected patients with lipodystrophy. The labeled indication reads:EGRIFTA™ is a growth hormone releasing factor (GRF) analog indicated for the reduction of excess abdominal fat in HIV-infected patients with lipodystrophy. (1)Limitations of use (1):• Long-term cardiovascular benefit and safety of EGRIFTA™ have not been studied.• Not indicated for weight loss management (weight neutral effect).• There are no data to support improved compliance with antiretroviral therapies in HIV-positive patients taking EGRIFTA™.Since this is the first drug approved for this use, coupled with the fact that there are lingering safety questions to be addressed, FDA will present a stakeholder teleconference on Thursday, December 2, 2010 at 2 PM EST to discuss Egrifta (tesamorelin). FDA staff, including review division representatives will be providing an overview, and responding to caller questions. As we near the date for the teleconference, call-in information, supporting documents and an agenda will be forwarded. Please let us know your availability to participate on the call by contacting Helene.Clayton-Jeter@.... Please feel free to let others who you think are interested in this topic know about the opportunity to hear about the approval, and ask questions that may help you in responding to inquiries from your own constituents. Anyone interested in participating should contact Helene so we can get a general count of participants before the call. Best,