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Post by almannlives on Dec 31, 2016 9:51:56 GMT -5
Just curious about the possibility of a label change,and when it might happen. Thanks in advance. Oh and yes I'm a newbie so not sure if this already been beaten to death.
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Post by cjm18 on Dec 31, 2016 11:47:36 GMT -5
Hopefully approved by the end of 2017 as the only in class ultra rapid acting insulin. Correct me if I am wrong but the review period is 10 months by the FDA.
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Post by matt on Dec 31, 2016 15:05:29 GMT -5
Review periods depend on the category in which FDA places a label change. Some are trivial, like ink and font changes, and those make it through in a few days, others take a long time. I think the initial response to a label change on an already approved drug is due within six months after filing, but the initial response can be to ask for more data which may extend the process years. A lot depends on exactly what the company wants the label to say and whether they have the data to back it up.
What they need to overcome is the chart shown in the current label which clearly shows that absorption is fast, but the dynamics of glucose changes are about the same as other insulins. FDA is not going to give the desired label copy unless the onset of action is consistent with the rate of absorption, and there a number of reasons why those numbers may be different.
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Post by Deleted on Jan 1, 2017 9:40:23 GMT -5
What they need to overcome is the chart shown in the current label which clearly shows that absorption is fast, but the dynamics of glucose changes are about the same as other insulins. FDA is not going to give the desired label copy unless the onset of action is consistent with the rate of absorption, and there a number of reasons why those numbers may be different. The dynamics of Afrezza and analogues are NOT the same despite a coincidental data point. While Afrezza peaks at approximately 53 minutes and then decreases to baseline at 160 minutes, Lispro continues to rise and does not peak until approximately 120 minutes and stays elevated for over 240 minutes. Hence the reason analogues have a greater probably of causing hypoglycemia than Afrezza. |
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