The FDA has told Adolor and GSK that it will take three more months to review Entereg, a anti-constipation drug candidate. The agency is now expected to announce its decision on May 10. Recently, an FDA advisory committee narrowly endorsed the drug, saying that the benefits of the drug outweigh the potential risk of heart attacks that has been associated with Entereg. Adolor also submitted an updated risk management plan for the drug today.
GSK and Adolor have been attempting to gain FDA approval for Entereg since 2006, when the agency issued an approval letter and asked the companies for additional safety data.
- see this release [1] for more
Related Articles:
Entereg wins key FDA advisory committee vote. Report [2]
Adolor shares rise on NDA news. Report [3]
Investors cheer FDA's acceptance of Entereg response. Report [4]
FDA wants more safety data on Entereg. Report [5]
Adolor shelves Entereg studies; shares plunge. Report [6]
FDA needs more data on Adolor drug. Report [7]
Adolor hit by FDA's approvable letter for Entereg. Report [8]
Links:
[1] http://www.fiercebiotech.com/press-releases/fda-extends-review-nda-entereg-alvimopan
[2] http://www.fiercebiotech.com/story/entereg-wins-key-fda-advisory-committee-vote/2008-01-24?utm_medium=nl&utm_source=link
[3] http://www.fiercebiotech.com/story/also-noted-adolor-shares-rise-nda-news-indevus-plans-phase-iii-exelixis-earns-milestone-and-mu
[4] http://www.fiercebiotech.com/story/investors-cheer-fdas-acceptance-entereg-response/2007-08-28
[5] http://www.fiercebiotech.com/story/fda-wants-more-safety-data-on-entereg/2007-06-11
[6] http://www.fiercebiotech.com/story/adolor-shelves-entereg-studies-shares-plunge/2007-04-10
[7] http://www.fiercebiotech.com/story/fda-needs-more-data-on-adolor-drug/2005-07-22
[8] http://www.fiercebiotech.com/story/adolor-hit-by-fda-s-approvable-letter-for-entereg/2006-11-06