FDA Panel Backs Inhaled Insulin

A Food and Drug Administration advisory committee has voted to recommend Pfizer's ( PFE) Exubera, an inhaled insulin product, despite concerns about the drug's long-term effects, especially on people with lung disease.

The panel of endocrinologists voted 7-2 Thursday to recommend Exubera to treat both type 1 and type 2 diabetes. If approved, Exubera would be the first inhaled insulin product on the market.

The panel was split on whether to recommend the drug for diabetes patients who smoke, are exposed to cigarette smoke or have lung disease. Insulin absorption in those patients could vary significantly from those without lung disease and exposure to smoke. The FDA isn't required to act on the committee's recommendation. However, normally the agency does follow the advice of its panels.

While research indicates that the drug is as effective as currently available injectible insulin, the inhaled version comes with another set of side effects. According to Pfizer's safety and efficacy trials, next to hypoglycemia, or low-blood sugar (which also occurs with injected insulin), the most common side effects of Exubera were respiratory tract infections, cough and an inflammation called pharyngitis.

Exubera was co-developed with Nektar Therapeutics ( NKTR) and Sanofi-Aventis ( SNY).

Pfizer may submit additional safety data on Exubera to ease worries about long-term side effects. In safety trials, 821 patients were treated for more than two years and 153 were treated for more than three years, but only 15 patients were treated for more than seven years.

Something that's still unclear is whether different techniques in using the inhalation device lead to varied doses of Exubera being absorbed into the lungs. If so, doctors and patients could require time to learn to use the inhalation device properly, which could slow the drug's acceptance among diabetics and health professionals.

While it may seem that inhaled insulin is the answer for noncompliant or needle-fearing diabetics, if the drug is even approved, some patients may still be required to keep their needles. Exubera is the inhaled version of a type of insulin taken after meals, but many diabetics require baseline insulin, which is longer-acting and still only available by injection.

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