FDA Approves First Inhalable Insulin
FDA on Friday approved Exubera, the first inhalable form of insulin, for use in diabetes patients, the AP/Houston Chronicle reports. Pfizer developed Exubera, which is delivered in powder form through a small dispenser, with Sanofi Aventis and Nektar Therapeutics.
In clinical trials, Exubera was as effective as injected insulin in the management of blood sugar levels in diabetes patients (Bridges, AP/Houston Chronicle, 1/28). FDA approved Exubera to stabilize blood sugar levels near mealtimes among adult patients who have type 1 or type 2 diabetes and do not smoke.
FDA also said that diabetes patients who quit smoking within the previous six months or who have lung diseases such as emphysema, bronchitis or asthma should not use Exubera. Trial data reviewed by FDA indicated that diabetes patients who live with smokers or who have mild respiratory infections, such as colds, can safely use Exubera (Manning, USA Today, 1/30).
Exubera will not replace the need for some diabetes patients to inject insulin in the morning or at night, FDA said. FDA also said that diabetes patients should have their lungs examined before they begin to use Exubera and at six- and 12-month intervals subsequently (AP/Houston Chronicle, 1/28).
According to Robert Meyer, director of the FDA office that evaluates diabetes medications, said the agency will require Pfizer to conduct post-market trials of Exubera, one of which will include 5,000 participants and examine whether lung problems develop among those who use the medication over a five-year period (USA Today, 1/30).
Pfizer said that Exubera should become available by the middle of 2006. Analysts estimate that Exubera will have sales of as much as $2 billion annually within five years. FDA could approve a second inhaled insulin treatment next year (Japsen, Chicago Tribune, 1/28).
Eli Lilly, Kos Pharmaceuticals, Novo Nordisk and MannKind have begun to develop inhaled insulin treatments (USA Today, 1/30).
Several broadcast programs reported on the approval of Exubera:
- ABCNews' "World News Tonight": The segment includes comments from Nathaniel Clark, a physician and vice president of clinical affairs for the American Diabetes Association; Meyer; and participated in trials of Exubera (Harris, "World News Tonight," ABCNews, 1/27).
- NBC's "Nightly News": The segment includes comments from Stephen Davis, a physician at Vanderbilt University Medical Center; Hank McKinnell, CEO of Pfizer; and Meyer (Costello, "Nightly News," NBC, 1/27). The complete segment is available online in Windows Media.
- NPR's "Weekend Edition Saturday": The segment includes comments from Clark, Galson and Meyer (Silberner, "Weekend Edition Saturday," NPR, 1/28). The complete segment is available online in RealPlayer.