News on Wellness

FDA Gives a Go Ahead to MannKind’s Inhaling Insulin Drug for Diabetic Patients

FDA

The inhaled insulin drug, developed and manufactured by Mannkind has found its way after getting thumbs up from the Endocrinologic and Metabolic Drugs Advisory Committee of the U.S. Food and Drug Administration for marketing. And, this resourceful drug will find its way into the markets under the brand name Afrezza.

FDA

Afrezza was voted 13-1 by the FDA panel of advisors to be used by individuals who should improve glycemic control due to type-1 diabetes and was voted 14-0 for patients of type-2 diabetes.

The delivery system of the drug and its action is expected to be the fastest acting mealtime insulin therapy available, provide it manages to find its way to the markets this year.

Prior to the polling, the FDA panelists discussed the safety issues related to the inhaled medication, mainly the eventual loss of pulmonary function over time, degeneration, and also the risks of lung cancer. The main reason that adds to this extensive discussion on the drug was that the earlier version of inhaled insulin called Exubera, manufactured by Pfizer was linked to an increase in lung cancer cases.

This approval has come after three attempts to seek Afrezza’s approval as means to improve glycemic control in individuals suffering from diabetes. In the year 2011, its approval was denied due to insufficient data. Again in 2013, it was denied the approval from FDA, as they needed more labeling and clinical data. However, the third time, the drug seemed to be a true charm.

“Barriers that limit effective glycemic control and impeded compliance with starting/maintaining insulin therapy, such as clinical inertia, suboptimal insulin dosing and use, and fear of weight gain and hypoglycemia, contribute substantially to a patient’s glycemic burden,” stated the Mannkind Corporation in its most recent briefing document submitted to the FDA.

The firm also mentioned that previous insulin initiation is still a vital unmet medical requirement. Few significant extra therapeutic choices for individualized DM management could be new insulin therapies that offer clinical benefits, and ease of usage.

 

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