Saturday, January 28, 2006

FDA Approves Inhaled Insulin - In Stores By Summer

The FDA yesterday approved Exubera®, the powered inhalable insulin developed by Pfizer and Sanofi-Aventis, for the treatment of diabetes. (Pfizer since acquired sole worldwide rights.)

Inhaled insulin is a breakthrough for the drug's administration which until now required injection - by needle, pen, or pump. Insulin cannot be taken orally since the protein is broken down by digestive enzymes. Exubera is designed to enter the lungs though the mouth via an inhaler, originally designed by Nektar Therapeutics (shown).

Inhaled insulin has the potential to ease the burden of injection, but there are a few caveats:
  • It's not recommended for smokers, those with asthma, bronchitis, emphysema, or other unstable lung conditions.
  • Currently, it can only replace the short-acting, bolus dose of insulin. If a longer-acting basal dose is needed, that would need to be injected.
Price may also be a consideration. The New York Times reports that:
"Exubera would cost between $120 and $150 a month, roughly comparable to the price of pills taken by some people with Type 2 diabetes but about three times the price of injectable insulin."

Exubera should be available by prescription this summer. Pfizer has posted the following hotline for consumers or health care providers who'd like more information: 1-800-EXUBERA.


FDA Press release:
FDA Approves First Ever Inhaled Insulin Combination Product for Treatment of Diabetes

Pfizer press release:
Pfizer Receives FDA Approval for Exubera, the First Inhalable Form of Insulin for Controlling Type 1 and Type 2 Diabetes in Adults

Some news summaries:
US Regulators Approve Insulin in Inhaled Form
FDA Approves Inhaled Insulin for Diabetics