The Latest Developments
On Wednesday afternoon, MannKind announced that the FDA had sent the company a CRL for its most recent re-application for its Afrezza inhaled insulin. This time the FDA's concerns were about potential differences between the MedTone inhaler used in past pivotal studies and the next-generation device that the company intends to actually launch with approval.
The FDA has now determined that the company needs to run at least two additional new studies (one in Type 1 diabetics and one in Type 2 diabetics) to determine if all of the relevant data is equivalent between the two devices. The FDA also wants at least one arm of one of the studies to include patients using the older MedTone device so that there can be head-to-head comparisons. (For related reading, check out The Curious And Complicated Case Of MannKind.)
To some extent, this is a legitimate request from the FDA. It is fair for the agency to want to confirm that the two devices work in basically the same fashion and produce the same outcomes in patients. Moreover, the FDA's request that the study include at least 12 weeks of consistent use (after a titration period) is not terribly onerous either - after all, diabetes drug studies often run at least a year, and the FDA increasingly seems to be demanding a minimum of two years of data.
In addition to the head-to-head comparison, the FDA wants more mundane data like information on the new device, updated safety information and so forth. (For more, see Dark Days In Diabetes.)
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