FDA Delays Decision on Inhaled Insulin

Inhaled Insulin

| May 6, 2014

The Food and Drug Administration (FDA) has delayed until July 15th whether to allow the inhaled insulin Afrezza entry into the American market.

Manufactured by Valencia, Calif.-based MannKind Corp., Afrezza uses a small inhaler that delivers insulin powder into the lungs. It is aimed at both type 1 and type 2 people with diabetes.

The technology takes advantage of the lungs' ability to deliver the insulin directly into the bloodstream, bypassing the need to inject the drug.

The FDA's extension of its review process centers on concerns about possible ill effects on users' lungs, including the risk of lung cancer. Although an FDA advisory panel recently voted overwhelmingly* to give a thumbs up to marketing Afrezza, it also recommended longer term studies to address the drug's possible effects on lungs.

If Afrezza is finally approved for U.S. sales, it would be the first inhalable insulin on the American market since 2006 when Exubera was introduced. Produced by Pfizer, the drug failed to catch on among users or prescribers, and Pfizer withdrew it from the U.S. market in 2007.

Mannkind first applied to the FDA to approve Afrezza in 2010. The FDA rejected the application in 2011, calling for additional clinical trials.

Under the three-month delay mandated by the FDA, Mannkind will be required to produce results from all of its Afrezza trials for review by the agency.

* The panel voted 13 to 1 to approve Afrezza for use with type 1 adults, and unanimously to

approve it for use with type 2 adults.

Click Here To View Or Post Comments

Categories: Afrezza , Diabetes, Exubera, Food and Drug Administration (FDA), Inhalable Insulin, Insulin, MannKind Corp, Type 2


Take the Diabetes Health Pump Survey
See What's Inside
Read this FREE issue now
For healthcare professionals only

You can view the current or previous issues of Diabetes Health online, in their entirety, anytime you want.
Click Here To View

See if you qualify for our free healthcare professional magazines. Click here to start your application for Pre-Diabetes Health, Diabetes Health Pharmacist and Diabetes Health Professional.

Learn More About the Professional Subscription

Free Diabetes Health e-Newsletter

Latest
Popular
Top Rated
Print | Email | Share | Comments (0)

You May Also Be Interested In...


Comments


Add your comments about this article below. You can add comments as a registered user or anonymously. If you choose to post anonymously your comments will be sent to our moderator for approval before they appear on this page. If you choose to post as a registered user your comments will appear instantly.

When voicing your views via the comment feature, please respect the Diabetes Health community by refraining from comments that could be considered offensive to other people. Diabetes Health reserves the right to remove comments when necessary to maintain the cordial voice of the diabetes community.

For your privacy and protection, we ask that you do not include personal details such as address or telephone number in any comments posted.

Don't have your Diabetes Health Username? Register now and add your comments to all our content.

Have Your Say...


Username: Password:
Comment:
©1991-2014 Diabetes Health | Home | Privacy | Press | Advertising | Help | Contact Us | Donate | Sitemap

Diabetes Health Medical Disclaimer

The information on this site is not intended or implied to be a substitute for professional medical advice, diagnosis or treatment. All content, including text, graphics, images, and information, contained on or available through this website is for general information purposes only. Opinions expressed here are the opinions of writers, contributors, and commentators, and are not necessarily those of Diabetes Health. Never disregard professional medical advice or delay seeking medical treatment because of something you have read on or accessed through this website.