Friday, March 28, 2014

Mannkind Adcom Prediction

I predict a positive vote at Tuesday's ADCOM meeting for Mannkind MNKD with the following caveats based on the briefing documents.  I've provided some of the FDA reviewers comments below. 

-  Type 2 diabetes only (Type 1 not approved)
-  Limited use to restrict patients with lung disease (asthma, COPD, etc) or at high risk of lung disease (ie smokers)


In conclusion, the available data from clinical pharmacology studies for
AFREZZA does not conclusively support use in patients with underlying lung diseases.  The data from clinical studies will be considered along with the available limited PK results to develop
the final labeling recommendations.

Reviewer’s comment: The study results show that the primary objective of noninferiority
of Afrezza TI Gen2 to insulin aspart was met (noninferiority margin 0.4%). However, Afrezza TI Gen2 was statistically worse than insulin aspart. (Type 1 comment)
 
The FDA statistician also performed extensive sensitivity analyses for study 175 and
verified the Sponsor’s sensitivity analyses. In brief, the FDA statistician concluded that
sensitivity analyses supported the superiority finding. (Type 2 comment)
 




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