FDA
5th December 2013

Meeting Materials NOW Available! – vedolizumab

During this joint meeting, the committees will discuss two biologics license applications (BLAs) for vedolizumab injection (proposed tradename Entyvio), submitted by Takeda Pharmaceuticals, USA Inc. BLA 125476 proposes an indication for the treatment of adult patients with moderately to severely active ulcerative colitis who have had an inadequate response to, have lost response to, or were intolerant to either conventional therapy or a tumor necrosis factor-alpha (TNFα) antagonist.

Meeting Materials NOW Available! – vedolizumab


December 9, 2013 8:00 a.m. to 5:30 p.m.: Joint Meeting of the Gastrointestinal Drugs Advisory Committee (GIDAC) & Drug Safety and Risk Management Advisory Committee (DSaRM) Meeting 

During this joint meeting, the committees will discuss two biologics license applications (BLAs) for vedolizumab injection (proposed tradename Entyvio), submitted by Takeda Pharmaceuticals, USA Inc. BLA 125476 proposes an indication for the treatment of adult patients with moderately to severely active ulcerative colitis who have had an inadequate response to, have lost response to, or were intolerant to either conventional therapy or a tumor necrosis factor-alpha (TNFα) antagonist. BLA 125507 proposes an indication for the treatment of adult patients with moderately to severely active Crohn’s disease who have had an inadequate response to, have lost response to, or were intolerant to either conventional therapy or a TNFα antagonist. 

Please click HERE to access the FDA meeting materials associated with this meeting. In the meeting materials, you will find the original meeting announcement, the agenda, committee roster(s), webcast information, FDA proposed questions and other relevant briefing information.

You can access the current roster of the Gastrointestinal Drugs Advisory Committee HERE, and the current roster of the Drug Safety and Risk Management Advisory Committee HERE.

ISS has over a decade of experience in developing regulatory strategies including support for FDA Advisory Committee meetings. We are involved in more FDA AdComms per year than even the largest pharmaceutical companies. For more information on how ISS can help you prepare for your next meeting, contact info@innovativescience.net.

Do you want to find out what happens during this drug’s FDA AdComm meeting? Great news – ISS can help you! Click on the link below in order to receive a summary of this meeting’s outcome! 

Drug AdComm Follow-up Request

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