Is Efficacy Of Afrezza TI "Modest" In Type2 Diabetes
Mar 31, 2014 14:42:28 GMT -5
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Post by silentbob on Mar 31, 2014 14:42:28 GMT -5
In Affinity2 (TI-175) we showed only a -0.4 A1c benefit versus placebo.
While this is clearly significant and approvable, there is no denying that -0.4 A1c is a modest benefit.
Does that mean panel members will conclude that Afrezza efficacy is modest in general?
I do not believe so. Ofcourse there are the arguments that A1c is a poor measure and that PPG and glycemic variation or even mean blood glucose are better measurements, but even in A1c Mannkind can and will argue that Afrezza efficacy is quite significant.
Some of this evidence is in the FDA's own briefing;
- In study 005 Afrezza reached up to -0.8 A1c change vs placebo at higher doses because (placebo was +0.2 in that trial).
- In 102 Afrezza performance was nearly identical to NovoLog Mix 70/30
- In 103 Afrezza performance was nearly identical to a secretagogue (oral drug)
- Also in 103 Afrezza replaced TWO orals and A1c only worsened by +0.2.
I'm sure there is much more supporting evidence in the Mannkind documents so I would not worry about the "modest" efficacy for Type2.
While this is clearly significant and approvable, there is no denying that -0.4 A1c is a modest benefit.
Does that mean panel members will conclude that Afrezza efficacy is modest in general?
I do not believe so. Ofcourse there are the arguments that A1c is a poor measure and that PPG and glycemic variation or even mean blood glucose are better measurements, but even in A1c Mannkind can and will argue that Afrezza efficacy is quite significant.
Some of this evidence is in the FDA's own briefing;
- In study 005 Afrezza reached up to -0.8 A1c change vs placebo at higher doses because (placebo was +0.2 in that trial).
- In 102 Afrezza performance was nearly identical to NovoLog Mix 70/30
- In 103 Afrezza performance was nearly identical to a secretagogue (oral drug)
- Also in 103 Afrezza replaced TWO orals and A1c only worsened by +0.2.
I'm sure there is much more supporting evidence in the Mannkind documents so I would not worry about the "modest" efficacy for Type2.