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Takeda / Millennium Pharmaceuticals Entyvio FDA Advisory Committee Meeting

12/09/2013 - 08:00
12/09/2013 - 17:30

FDA Advisory Committee Recommends Approval of Takeda’s Investigational Biologic Vedolizumab

Takeda announces positive vote on vedolizumab to treat ulcerative colitis
and Crohn’s disease

Deerfield, Ill., December 9, 2013 and Osaka, Japan, December 10, 2013 -- Takeda Pharmaceutical Company Limited (“Takeda”) and its wholly-owned subsidiary, Takeda Pharmaceuticals U.S.A., Inc., today announced that a joint panel of members from the
Gastrointestinal Drugs and Drug Safety and Risk Management Advisory Committees of the United States (U.S.) Food and Drug Administration (FDA) voted to recommend approval of Takeda’s vedolizumab for the treatment of adults with moderately to severely active ulcerative colitis (UC) and Crohn’s disease (CD). All 21 committee members voted that based on currently available efficacy and safety data, the benefits outweigh the potential risks of vedolizumab to support approval for UC. Specifically, 13 committee members supported approval for UC patients who have failed steroids or immunosuppressants or TNF-α antagonists, while eight
committee members supported approval for UC patients who have failed immunosuppressants or TNF-α antagonists (the indicated population would not include patients that failed steroids only). Twenty of the 21 committee members voted to support approval for CD. Specifically, 14 committee members supported approval for CD patients who have failed steroids or immunosuppressants or TNF-α antagonists while six supported approval for CD patients who have failed immunosuppressants or TNF-α antagonists (the indicated population would not include patients that failed steroids only).
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Source: press release, 12/09/13. http://www.takeda.com/news/files/20131210_04_en.pdf

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December 9, 2013: Joint Meeting of the Gastrointestinal Drugs Advisory Committee (GIDAC) & Drug Safety and Risk Management Advisory Committee (DSaRM) Meeting Announcement
Center Date Time Location
CDER December 9, 2013
8:00 p.m. to 5:30 p.m.
FDA White Oak Campus
Building 31
The Great Room (Rm. 1503)
White Oak Conference Center
10903 New Hampshire Avenue
Silver Spring, Maryland
Agenda

On December 9, 2013, the committees will discuss two biologics license applications (BLAs) for vedolizumab injection (proposed tradename Entyvio), submitted by Millennium Pharmaceuticals, 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.

Meeting Materials

FDA intends to make background material available to the public no later than 2 business days before the meeting. If FDA is unable to post the background material on its Web site prior to the meeting, the background material will be made publicly available at the location of the advisory committee meeting, and the background material will be posted on FDA’s Web site after the meeting.

Background Material

2013 Meeting Materials, Gastrointestinal Drugs Advisory Committee
Public Participation Information

Interested persons may present data, information, or views, orally or in writing, on issues pending before the committee.

Written submissions may be made to the contact person on or before November 22, 2013.
Oral presentations from the public will be scheduled between approximately 1:30 p.m. to 2:30 p.m. on December 9, 2013. Those desiring to make formal oral presentations should notify the contact person and submit a brief statement of the general nature of the evidence or arguments they wish to present, the names and addresses of proposed participants, and an indication of the approximate time requested to make their presentation on or before November 14, 2013.
Time allotted for each presentation may be limited. If the number of registrants requesting to speak is greater than can be reasonably accommodated during the scheduled open public hearing session, FDA may conduct a lottery to determine the speakers for the scheduled open public hearing session. The contact person will notify interested persons regarding their request to speak by November 15, 2013.

Webcast Information

CDER plans to provide a free of charge, live webcast of the December 9, 2013, joint meeting of the Gastrointestinal Drugs Advisory Committee and Drug Safety and Risk Management Advisory Committee. While CDER is working to make webcasts available to the public for all advisory committee meetings held at the White Oak campus, there are instances where the webcast transmission is not successful; staff will work to re-establish the transmission as soon as possible. Further information regarding the webcast, including the web address for the webcast, will be made available at least 2 days in advance of the meeting at the following website: 2013 Meeting Materials, Gastrointestinal Drugs Advisory Committee
CDER plans to post archived webcasts after the meeting, however, in cases where transmission was not successful, archived webcasts will not be available.
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Source: FDA.gov. http://www.fda.gov/AdvisoryCommittees/Calendar/ucm371059.htm