Inhaled insulin for diabetics wins FDA's OK
Pfizer product is touted as a needle-free option
WASHINGTON -- The Food and Drug Administration yesterday approved the nation's first needle-free insulin, an inhaled powder that analysts expect will become a blockbuster.
Of the 18 million Americans diagnosed with diabetes, about 5 million must take daily shots to regulate blood sugar. Left unchecked, high blood sugar levels can result in a host of ailments -- such as blindness, nerve damage, and heart and kidney disease -- and even comas.
The inhaled insulin, called Exubera, will be marketed by
Many diabetics balk at painful insulin injections, and the American Diabetes Association estimates 15 percent of Americans diagnosed with diabetes under-treat themselves.
Exubera ''will be a really big deal," predicted Dr. Robert Gabbay, who co-directs Pennsylvania State University's Diabetes Center and was a participant in an early clinical trial.
The FDA was quick to say that not all diabetics will be able to completely replace their injections with Exubera.
People with type 1 diabetes need injections to live because their bodies produce only a small amount of insulin. In addition to taking short-acting insulin with meals to minimize blood sugar spikes after eating, they must take longer-acting insulin when they wake and go to bed. The FDA said those patients will still have to inject some insulin along with taking Exubera.
Up to 95 percent of Americans with diabetes have type 2, which is associated with aging, obesity, genetics, ethnicity, and lack of exercise, according to the National Institutes of Health. They either do not produce enough insulin or their bodies cannot use it effectively. Many can control their blood sugar levels through careful diet, exercise, and oral medications that don't contain insulin. They will be able to use Exubera alone, or may have to use it in combination with pills or insulin injections.
Some diabetics, like Amy Driscoll, an American Diabetes Association volunteer in Boston, use insulin pumps. Driscoll had been giving herself as many as six shots daily, alternating between shots to her arms, legs, and stomach, until she switched to a pump in 2001. The device, about the size of a pager, rests on her waistband and releases steady pulses of insulin into tubing that leads to her stomach.
Driscoll, who researches diabetes' impact on the brain, said she's willing to try Exubera ''just to see how it works for me," but she wants to make sure it is as safe and reliable as her pump.
Analysts expect Exubera to generate $1 billion in US sales by 2009, and Pfizer believes sales could be higher.
''The medical need is certainly well beyond that," Pfizer chief executive Hank McKinnell told CNBC, adding that the company is three years ahead of competitors working on needle-free insulin therapies.
For now, Pfizer and Nektar Therapeutics Inc., which invented the insulin formulation and inhaler, will enjoy a monopoly in the marketplace.
''It's always a benefit to be the first in class," said Jason Napodano, a Zacks Investment Research analyst. ''You corner as much of the market as you can. But, just because you're first doesn't necessarily mean that you're best."
At least a half dozen other drug companies are working on inhalable insulin therapies. The closest to market is a product developed by Cambridge-based
The FDA's approval for Exubera occurred one day after the agency approved Pfizer's oral cancer therapy, and European regulators gave their OK to Exubera. These are ''exciting developments for patients and investors in the last 24 hours," McKinnell told CNBC.
The company stock closed yesterday at $25.99, up 3.75 percent on the New York Stock Exchange.
Exubera's development had been delayed by years because of safety concerns, including coughing, shortness of breath, sore throats, and dry mouths experienced by subjects in clinical trials.
On Sept. 8, 2005, federal advisers endorsed Exubera as a treatment for type 1 and 2 diabetics. The 7-2 vote occurred despite concerns about the drug's safety for smokers, and people with asthma and upper respiratory infections.
Federal regulators delayed their decision, expected in October, by three months. Ultimately, the FDA approved the drug's use by adults who do not have underlying lung problems. The agency has banned the drug's use by smokers or people who quit smoking in the previous six months.
Patients will receive guides with their prescriptions to ensure they administer the correct dose. The FDA also recommends patients get tests to check lung function before using Exubera. To ensure their lung function does not decline while using Exubera, patients will undergo follow-up tests every six months to a year.
''This product is not for everybody," said Dr. Robert Meyer, who oversees the FDA's division of metabolic and endocrine drugs. Smokers, for instance, experienced supersized concentrations of Exubera when they inhaled it, according to Pfizer's own studies.
''They would be facing potential overdoses," Meyer said. ''If that was an unpredictable overdose, it could be very problematic and dangerous."
On Thursday, the FDA approved Pfizer's Sutent to treat a rare stomach cancer and advanced kidney cancer. The decision was the first time federal regulators approved two uses for a single cancer therapy on the same day. Analysts project Sutent, which starves tumors of the blood and nutrients they need to grow, will also generate $1 billion in sales.
This week's regulatory actions encouraged investors who last week were told Pfizer lost $5.7 billion in worldwide revenue in 2005 because of expired patents, market withdrawal of the painkiller Bextra, and dampened sales of its chemical cousin Celebrex. Investors are bracing for generic drugs to battle with Pfizer's Zoloft, an antidepressant; Norvasc, a blood pressure treatment; and Zyrtec, an allergy remedy. The trio generated $9.3 billion in sales in 2005.
Diedtra Henderson can be reached at dhenderson@globe.com. 
