During this meeting, the Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) discussed the new drug application (NDA) 22-472.
During this meeting, the Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) discussed the new drug application (NDA) 22-472, proposed trade name AFREZZA (TECHNOSPHERE Insulin Inhalation System), manufactured by MannKind Corporation.
Afrezza is a drug-device combination inhaler consisting of Afrezza Inhalation Powder single use dose cartridges. Afrezza is an ultra rapid-acting mealtime insulin therapy intended for glycemic control in adult patients with type 1 or type 2 diabetes mellitus.
In this meeting, there were 5 discussion questions and 2 voting questions. The vote regarding whether Afrezza should be approved for the more common, type 2 diabetes, resulted in a unanimous 14 to 0 in favor of approval. Regarding whether the drug should be approved for type 1 diabetes, 13 voted yes in support of approval while 1 voted against approval.
In the main trial for Type 1 diabetes patients, Afrezza was less effective than injected insulin in reducing blood sugar. Nonetheless, Afrezza still met the statistical criterion for success in the trial.
In the clinical trial for patients with Type 2 diabetes, the agency noted that Afrezza was better than an inhaled placebo, but the effect was “modest” compared with what was seen in the trials of many other diabetes drugs.
Dr. Robert J. Smith, an endocrinologist at the Alpert Medical School at Brown University and the committee’s acting chairman, commented on Afrezza after the vote, “As an inhaled form of insulin, this represents a drug that will serve some patients that are not effectively served by currently available insulin.”
In previous years, MannKind had failed to gain FDA approval, requiring the company to perform new clinical trials in order to get another shot at approval. If approved this time around, Afrezza would be the first ultra rapid-acting mealtime insulin therapy available in the U.S.
The agency is not obligated to follow its committee’s recommendation, but normally does so.
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