Inhaled insulin Afrezza approved by US FDA

Mon, 30 Jun 2014
A new inhaled form of insulin, Afrezza, has been officially granted approval in the USA by the Food and Drug Administration (FDA).

Afrezza is an insulin powder that is inhaled using a small inhaler that is not much larger than the size of your thumb. The inhaled insulin is rapid-acting and is taken at meal times. Afrezza is not intended to replace long acting (basal) insulin.

The approval of the insulin is positive news for people that experience significant discomfort in taking multiple injections per day. People in the UK, however, will need to wait for further news as to whether the National Institute for Health and Care Excellence (NICE) will recommend the insulin in the UK.

Afrezza has been tested for safety and effectiveness in people with type 1 and type 2 diabetes. 1,026 people with type 1 diabetes and 1,991 people with type 2 diabetes took part in clinical trials which showed the treatment to be effective at reducing blood glucose levels and HbA1c.

In patients with type 1 diabetes, the reduction in HbA1c was not as great as for patients on the injected insulin NovoRapid, however, the reduction was significant enough to be granted approval.

The treatment has not been advised for use in people who smoke, have asthma or chronic obstructive pulmonary disease (COPD). Side effects of the drug include a risk of hypoglycemia as well as possible throat irritation or pain.

Whilst Afrezza has been approved for use, the FDA will monitor further clinical studies (post marketing studies) which will test for safety and efficacy in children and to continue to review whether there is a risk of lung cancer.
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