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Human Genome Sciences Inc. Message Board

  • steverachbach steverachbach Oct 20, 2010 1:46 PM Flag

    Call for experts: AMLN CRL

    The most specific item I saw is this:

    <<In the complete response letter the FDA requested a thorough QT study with exposures of exenatide higher than typical therapeutic levels of BYDUREON. The tQT protocol would be agreed to by the FDA prior to study initiation. Additionally, the FDA has now requested the results of the DURATION-5 study to evaluate the efficacy, and the labeling of the safety and effectiveness, of the commercial formulation of BYDUREON.>>

    That is clipped from this article: http://www.rttnews.com/content/BreakingNews.aspx?Id=1449736

    Now, I get the first part. The QT is an interval that can be measured on an EKG (heart rhythm tracing) which is part of the normal cycle of each beat. However, if you have a prolonged QT interval, you are prone to rhythm disturbances, some of which can cause sudden death. Some QT syndromes are inherited, some develop on their own, and many are caused by medications. Apparently, there may be some problem with this drug at high levels.

    Then, the report gets a little fuzzy. It states, "Additionally, the FDA has now requested the results.." That sounds to me like the QT issue has been mentioned prior to "now."

    Then, the report gets MAYBE somewhat worrisome for us HGSI shareholders and that's why I am asking for expert opinions. The news report states the FDA has "Requested the results of the DURATION-5 study to evaluate the efficacy, and the labeling of the safety and effectiveness, of the commercial formulation of BYDUREON." What I take from that is that the FDA wants for AMLN to do a completely new safety and efficacy study of the "COMMERCIAL FORMULATION" of the drug. This implies, to me at least, that the results of the "Phase 3 formulation" (for lack of a better term) of the drug is not good enough. It seems that the FDA wants them to test a commercial batch of the medicine. If this is so, may not the FDA want to test a commercial batch of Benlysta before approval?

    Thanks,

    -- Steve

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