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ARNA Discussion Board
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Re: Is this the real life? Is this just fantasy?It hasn't been published yet to the best of my knowledge. And I've looked high and low. Couple others have looked as well. When Arena says "No MAJOR circulating metabolism (this is undoubtedly a typo and should be "metabolites"), the key word is "MAJOR". Major means essentially the same thing as "disproportionate". And the threshold for a metabolite to be considered disproportionate as per the FDA is 10%. Arena has commented several times about E's metabolites. But as sure as they were that there were no issues, it wasn't formally confirmed. Not until the completion of the human mass balance study. The FDA requires metabolites that exceed 10% to be further studied. Arena has none. There will be no surprise issues such as that seen with Oz wherein one of Oz's previously unknown (not exactly sure how the history of that whole matter unfolded - probably have to put a Celg Exec under some bright lights to figure that out) metabolites actually exceeded the 10% threshold. And from that revelation it was found that this disproportionate metabolite actually remained in the human system for far longer than Celg had previously guided and it exposed the half life of Oz being no better than Gilenya and it also affects the Lymphocyte Trafficking - i.e. the "rapid offset" for safety reasons that we have been accustomed to seeing ascribed to E in Arena's presentations. Through my limited readings on the subject the 10% threshold is considered by some to be arbitrary. But, for us, we don't really care because that is the threshold and that's what the FDA will be concerned with when the application for marketing approval is submitted. And doctors and opinion leaders will know that the half life of E is 1-1.5 days and that E has a rapid offset. That's a layman's explanation. There's a lot more to it than that. Perhaps one of our scientists will chime in. |
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Msg # | Subject | Author | Recs | Date Posted |
41015 | Re: Is this the real life? Is this just fantasy? | giannmi | 12 | 5/16/2019 1:04:47 PM |
41016 | Re: Is this the real life? Is this just fantasy? | Motohead125 | 13 | 5/16/2019 1:11:00 PM |
41022 | Re: Is this the real life? Is this just fantasy? - Etrasimod has no major ciculating metabolites | moegrabbedmythumb | 27 | 5/16/2019 2:24:21 PM |