There is a claim in the article that has been bothering me; the article states: "Very Important Potential Label - Afrezza is in phase III trials to potentially be the first-line drug therapy in type 2 diabetes."
It also states: " Currently Metformin, and not insulin, is the generally accepted first-line drug therapy (the very first-line therapy is unlikely to change from diet and exercise) for type 2 diabetics. We will see that there are reasons that Afrezza may show substantial superiority over the comparator in the Affinity 2 trial, a placebo of Technosphere particles with no insulin. That would position Afrezza as the recommended first-line drug treatment, either alone or along with Metformin, for type 2 diabetes."
The question that I have for the forum is: is there a chance that the FDA will label Afrezza alone as the recommended first-line drug therapy for type 2 diabetes?
From Mannkind's web-site: " The other study (study 175) is assessing AFREZZA using the next-generation inhaler in patients with type 2 diabetes whose disease is inadequately controlled on metformin with or without a second or third oral medication. After a run-in period during which the subjects remain on their oral medication, at least 328 patients will be randomized to additional treatment with AFREZZA or to Technosphere® inhalation powder (placebo). The study will also have a titration period, followed by a 12-week evaluation period to assess HbA1c levels."
My understanding of the MKC175 trial is that it compares metformin with metformin plus Afrezza. How does superiority in this trial lead the FDA to label Afrezza alone as the first-line drug therapy for type 2 diabetes if the trial does not have patients using Afrezza alone? Lia, your opinion on this would be appreciated.
Thanks,
Bob
