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news.US-based MannKind has received approval from the US Food and Drug Administration (FDA) for its new, rapid-acting inhaled insulin therapy AFREZZA (insulin human) inhalation powder to improve glycemic control in adult patients with diabetes mellitus.
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The inhalation powder in AFREZZA is delivered using a small, discreet and easy-to-use inhaler.
The company said that the AFREZZA should be administered at the start of a meal and it dissolves rapidly upon inhalation to the deep lung and delivers insulin quickly to the bloodstream.
Following inhalation peak insulin levels are achieved within 12 to 15 minutes of administration, and decline to baseline by about 180 minutes.
MannKind chief executive officer Alfred Mann said approval of AFREZZA is an important milestone for the company, as the FDA approval validates the years of clinical research and commitment that powered the development of this unique therapy.
"We are excited for patients, as we believe that AFREZZA’s distinct profile and non-injectable administration will address many of their unmet needs for mealtime insulin therapy, and has the potential to change the way that diabetes is treated," Mann said.
According to the company, AFREZZA must be used in combination with a long-acting insulin in patients with type 1 diabetes mellitus and it is not recommended for the treatment of diabetic ketoacidosis as well as for patients who smoke.