Exubera receives FDA approval
The US Food and Drug Administration (FDA) has approved Exubera, an inhaled powder form of recombinant human insulin (rDNA), for the treatment of adult patients with type 1 and type 2 diabetes.
The US Food and Drug Administration (FDA) has approved Exubera, an inhaled powder form of recombinant human insulin (rDNA), for the treatment of adult patients with type 1 and type 2 diabetes.
The drug, manufactured by Pfizer (New York, US), is the first new delivery option to have been introduced for insulin since its discovery in the 1920s.
It is a human form of insulin that lowers blood sugar concentrations by allowing blood sugar to be taken up by cells as a source of fuel. It is inhaled into the lungs through the patient's mouth using a specially designed inhaler.
In clinical studies, Exubera reached peak insulin concentration more quickly than some insulins, called regular insulin, administered by an injection. Peak insulin levels were achieved at 49 minutes (range 30 to 90 minutes) with Exubera, and at 105 minutes (range 60 to 240 minutes) with regular insulin.
In type 1 diabetes, inhaled insulin may be added to longer acting insulins as a replacement for short-acting insulin taken with meals. In type 2 diabetes, inhaled insulin may be used alone, along with oral (non-insulin) pills that control blood sugar, or with longer acting insulins.
Exubera will be the subject of long-term studies to confirm its continued safety and examine more thoroughly its efficacy and safety in patients with underlying lung disease.