This article is more than 5 years old. Information may no longer be current.

FDA advisory panel recommends approval for inhaled insulin

Add topic to email alerts

Receive an email when new articles are posted on

Please provide your email address to receive an email when new articles are posted on .

Subscribe

Added to email alerts

You've successfully added to your alerts. You will receive an email when new content is published.

Click Here to Manage Email Alerts

You've successfully added to your alerts. You will receive an email when new content is published.

Click Here to Manage Email Alerts

Back to Healio

We were unable to process your request. Please try again later. If you continue to have this issue please contact customerservice@slackinc.com.

Back to Healio

Today, the FDA Endocrinologic and Metabolic Drugs Advisory Committee voted to recommend approval of a drug ingested through an inhalation system to treat type 1 and type 2 diabetes.

The committee discussed the efficacy and safety of the three- and six-unit cartridges designed for oral inhalation. The drug (Afrezza, MannKind Corp.) has been proposed to improve glycemic control in adult patients with type 1 or type 2 diabetes.

The committee voted 13-1 (with one non-voting member) to recommend approval of the drug for use as a prandial medication in type 1 diabetes, and 14-0 (with one non-voting member) to recommend approval for use in type 2 diabetes.

The drug was first submitted to the FDA in March 2009, followed by “a complex regulatory history, including two previous cycles of review that resulted in issuance of Complete Response Letters on March 12, 2010 and January 18, 2011 due to multiple identified deficiencies in the application,” according to background documents provided by the FDA committee.