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Post by raydonovan on Feb 6, 2014 13:42:32 GMT -5
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Post by ashiwi on Feb 6, 2014 15:27:14 GMT -5
Link didn't work for me, so here is the full post.
Clinical utility clearly established by Afrezza/Dreamboat inhaler in FDA's eyes
In researching the term “clinical utility” I have found the definition relates to benefits derived from a new treatment vs existing treatments. Clinical utility could not be established by the FDA the first two times because different inhalers were used. Now that the data has been bridged, we can look at ALL the trials to determine if “clinical utility” has been sufficiently established for the FDA to approve. However, in researching this subject,in the FDA’s eyes there are lots of ways for a treatment to establish a benefit (clinical utility) over an existing treatment. So lets look at all the ways the FDA will consider.
CU = Clinical utility
- Efficacy:
T1 - neutral CU (non inferior, no comparative benefit existing RAAs or Afrezza)
T2 - yes CU over oral meds alone
- Safety Hypo
T1 - yes CU in statistical significant reduction in hypos
T2 - yes CU in statistical significant reduction in hypos over oral meds/Lantus
- Safety Other
T1 - neutral CU as there are no statistically significant differences in other material safety issues
T2 - neutral CU as there are no statistically significant differences in other material safety issues
- Weight Gain:
T1 - yes CU is neutral in weight gain over existing basal/RAA treatments
T2 - yes CU in less weight gain over oral med/Lantus
- Cost
T1 - yes CU due to reduction in costs associated with diabetic complications
T2 - yes CU due to reduction in costs associated with diabetic complications
- Quality of Life (Q of L)
T1 - yes CU due to increased Q of L due to reduced fear of hypos
T2 - yes CU due to increased Q of L because inhaled
- Dosage
T1 - yes CU due to ability to take after meal dosage with less fear of hypo
T2 - yes CU due to increased inability of user to over dose
- Usage
T1/T2 - yes CU due to ability to take immediately before meal, instead of 30 min.
- User training
T1/T2 - yes CU as less training required of inhaler then both pens or shots
- Physician acceptance
T1/T2 - yes CU survey shows 86% will prescribe
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