FDA approves New Afrezza label

[Thomas]

The Afrezza label update was approved.
Apparently the FDA sent the approval to MannKind privately so as to allow MannKind to decide when to release the information. Friday afternoon is often times seen as the best for bad news while Monday morning is often seen as the best for good news. It would appear that MannKind is following this tradition with an early Monday morning release of this information.

Key highlights of the label update:

1. Inclusion of study data that describe the time-action profile by dosage strength, showing first measurable effect starts in approximately 12 minutes, peak effects occur approximately 35 to 45 minutes after dosing and return to baseline after approximately 1.5 to 3 hours for the 4 and 12 unit cartridges respectively.
2. Clarity on “Starting” and “Adjusting” mealtime dose.
3. Updated pregnancy and lactation section to conform to current FDA label guidance.

FDA UPDATES AFREZZA® PRESCRIBING INFORMATION

This label update approval still does not negate the fact that MannKind is in a desperate cash crunch that needs to be resolved to allow the company to continue forward. However it may be beneficial in allow cash to be raised on more favorable terms.

[Thomas]

The label change was partially approved. Not everything asked for was approved.

MannKind had also asked for “Ultra Fast” categorization which would have been an entirely new category of insulin. This was not approved. Possibly the thought process on the part of the FDA was whether a new categorization for insulin was needed and would be helpful.

MannKind is going to work further with the ADA and JDRF on this aspect (Ultra Fast). I guess if those two organizations get behind the concept of a new category of “Ultra Fast” then an FDA label change request for this would have greater probability of successful outcome?

[Michel]

@Thomas

The Afrezza label update was approved.

This is great news, totally worth a new thread. Thanks for all the info, and the great analysis!