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FDA requests more data on inhaled insulin

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The FDA issued a complete response letter to MannKind Corporation requesting additional clinical trials to yield more information before approving an inhalable form of insulin.

The company submitted a new drug application for the ultra-rapid-acting mealtime insulin therapy (Afrezza Inhalation Powder) to control hyperglycemia in adults with type 1 and type 2 diabetes.

Issues of concern cited in the complete response letter focused on using in vitro performance data and clinical pharmacology data to advance the company’s next-generation device to phase 3 trials involving its previous inhaler (MedTone).

The FDA requested two clinical trials, including one in patients with type 1 diabetes and another in patients with type 2 diabetes, with at least one group using the MedTone inhaler to obtain head-to-head comparison data on the two devices. Further, the agency stated that, after an adequate titration of the medication, insulin dosing should be relatively stable for at least 12 weeks at the study’s conclusion.

According to a MannKind press release, the company has already started a series of studies in patients with type 1 and type 2 diabetes that focus on careful titration of insulin dose and include at least 12 weeks of stable dosing. The company said it is working with the FDA to make these data available and is “encouraged that the FDA is asking for clinical studies only to confirm the bridging and handling of the next-generation device in order to compare it to the device used in [the] extensive clinical program.”

The FDA’s complete response letter also included requests for more information on performance characteristics, usage, handling, shipment, storage and user training of the product.

The drug-device combination product consists of inhalation powder pre-metered into single-use dose cartridges and the inhaler. Administered at the start of a meal, the product dissolves immediately upon inhalation and delivers insulin, with peak levels achieved within 12 to 14 minutes of administration, according to the company.

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