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Post by peppy on Oct 5, 2017 9:02:03 GMT -5
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Post by itellthefuture777 on Oct 5, 2017 9:48:49 GMT -5
Sanofi and Mannkind are on it! do you know what this means! |
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Post by peppy on Oct 5, 2017 9:49:34 GMT -5
thanks for the thumbs up itell. 
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Post by itellthefuture777 on Oct 5, 2017 9:52:39 GMT -5
thanks for the thumbs up itell.
should put this item on the main board.. |
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Post by peppy on Oct 9, 2017 18:29:33 GMT -5
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Post by peppy on Oct 12, 2017 7:32:45 GMT -5
So Matt told us: the thinking/argument for the RAA,
You will have to convince FDA that the difference in clinically relevant. The current label reads as follows:
Absorption: The pharmacokinetic profiles for orally inhaled AFREZZA 8 units relative to
subcutaneously administered insulin lispro 8 units from a study in 12 patients with type 1
diabetes are shown in Figure 3(B). The maximum serum insulin concentration was reached
by 12-15 minutes after inhalation of AFREZZA 8 units and serum insulin concentrations
declined to baseline by approximately 180 minutes. However, the faster absorption of
insulin from Afrezza [see Figure 3(B)] did not result in a faster onset of activity compared to
insulin lispro [see Figure 3(A)].
*Now Afrezza is showing a faster onset of activity compared to insulin fiasp. Did Matt tell us? Is this the insurance coverage ticket? We are not blind, we can see.
Afrezza Label Update
In October 2017, the FDA approved an update to the Afrezza prescribing information to, among other things, include new clinical data that was presented at
the American Diabetes Association’s 76th Scientific Sessions in June 2016. The updates to the label consisted of updates to the Clinical Pharmacology,
Dosage and Administration, and Use in Specific Populations sections.
With respect to the Clinical Pharmacology section of the label, the section now includes data that describe the time-action profile of Afrezza by dosage
strength, showing that the first measurable effect starts in approximately 12 minutes, peak effects occur approximately 35 to 45 minutes after dosing and
return to baseline occurs after approximately 1.5 to 3 hours for the 4 and 12 unit cartridges, respectively.
With respect to the Dosage and Administration section of the label, the section was updated with “Step 1” to describe how patients on injected mealtime
insulin should initially be dosed on Afrezza. Additionally, “Step 2” was added to highlight that mealtime dose adjustments may be required based on the
individual metabolic needs and glycemic control goals.
With respect to the Use in Specific Populations section, the Pregnancy and Lactation portions were updated to conform to current FDA guidance and provide
healthcare providers with clearer risk benefit information for informed decision making in these populations.
In conjunction with the approved labeling revision, we also received a letter of Fulfillment of Post-Marketing Requirements for PMR 2166-2 and PMR
2166-3, satisfying two of the four post-marketing requirements for Afrezza as described in the 2014 FDA approval letter. files.shareholder.com/downloads/AMDA-22AIJ9/1756957659x0xS1193125-17-307995/899460/filing.pdf
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Post by peppy on Nov 30, 2017 14:03:23 GMT -5
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Post by peppy on Dec 29, 2017 21:00:50 GMT -5
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