While those with diabetes will be the biggest beneficiaries of the inhaled insulin just approved by the FDA, another large benefactor – but unlikely to receive much publicity for the achievement – is Nektar Therapeutics (San Carlos, California).

Late last week the FDA reported market approval of Exubera, a recombinant human insulin, from Pfizer (New York), with the drug delivered via an inhaler device developed by Nektar, for the treatment of both Type 1 and Type 2 diabetes.

As the first inhaled insulin on the market, Exubera is predicted to produce sales of up to $10 billion annually. And Nektar, which in partnership with Pfizer also developed the powdered, inhaleable form of the drug in addition to the delivery device – could reap 10% to 20% of sales and royalties, Joyce Strand, director of corporate communications for Nektar, told Medical Device Daily in September (MDD, Sept. 12, 2005).

In approving the drug, the FDA followed the advice of the Endocrinologic and Metabolic Drugs Advisory Committee, which last September voted to recommend its approval.

Strand at the time described the Nektar inhaler device as “like a thin soda pop can that extends like a telescope. The extended part is a clear chamber so you can see whether you've take a dose or not in a simple manner.“

Pulling a handle on the device, she said, “compresses the air, forces the air through the powder and makes it into a fine powder.“

Nektar said in a statement following the announcement of the FDA approval that it would “receive royalties on all marketed products, as well as revenue for the manufacture of the powders and the inhalation devices.“ It did not project what these amounts will be.

Pfizer is responsible for marketing, manufacturing and the clinical development of Exubera. Nektar provides support in the manufacturing process for Exubera insulin and manufactures the inhalers.

In its announcement of the approval, the FDA described Exubera as a “potential alternative for many of the more than 5 million Americans who take insulin injections.“

“Until today, patients with diabetes who need insulin to manage their disease had only one way to treat their condition,“ said Steven Galson, director of the FDA's Center for Drug Evaluation and Research. “It is our hope that the availability of inhaled insulin will offer patients more options to better control their blood sugars.“

Larry Deeb, MD, president-elect, science and medicine, of the American Diabetes Association (ADA; Alexandria, Virginia), said patients have to remember that Exubera is “just insulin.“

“It really is just insulin, and I think that's an important statement to make, and so in a sense it can be expected to do no more and no less than insulin does,“ Deeb told MDD. “The question really to me will be, are there people who won't take injections who might take inhaled insulin and that might be appropriate.“

Deeb said there clearly are certain groups of those with diabetes who will be most likely to benefit from inhaled insulin potentially: primarily those patients who do not currently take injections and those who intermittently take insulin and would be willing to take inhaled insulin and want to switch. However, he doesn't expect those with Type 1 diabetes who are on strict diets and regimens of insulin injections to switch. “You can't get that kind of vigor [for these patients] with inhaled insulin,“ he said.

The FDA said that the safety and efficacy of Exubera have been studied in about 2,500 adult patients with Type 1 and Type 2 diabetes. “In clinical studies Exubera reached peak insulin concentration more quickly than some insulin, called regular insulin, administered by an injection,“ the agency said.

Peak insulin levels were achieved at 49 minutes with Exubera inhaled insulin compared to 105 minutes with regular insulin, respectively.

However, Exubera prescriptions will be accompanied by a medication guide that the agency urges patients to adhere to for instructions on who is and who is not recommended to take Exubera.

The FDA specifically said that Exubera is “not to be used if you smoke or if you recently quit smoking,“ within the past six months. Exubera is also not recommended in patients with asthma, bronchitis or emphysema. Baseline tests for lung function are recommended to be repeated every six to 12 months thereafter, the FDA said.

“Like any insulin product, low blood sugar is a side effect of Exubera and patients should carefully monitor their blood sugars regularly,“ the FDA said. “Other side effects associated with Exubera therapy seen in clinical trials included cough, shortness of breath, sore throat and dry mouth.“

The agency also said it would continue to perform long-term studies on the insulin device “to confirm the continued safety of Exubera after it is marketed and to examine more thoroughly the issue of the efficacy and safety of Exubera in patients with underlying lung disease.“

The FDA approval followed an announcement the previous day that the European Union had approved Exubera for the treatment of adults with Type 2 diabetes older than 18 not adequately controlled with oral antidiabetic agents and requiring insulin therapy (MDD, Jan. 27, 2006). Exubera also was approved in Europe for the treatment of adults with Type 1 diabetes mellitus, in addition to long or intermediate acting injectable insulin, for whom the potential benefits of adding inhaled insulin outweigh the potential safety concerns.

Originally, Exubera was developed jointly by Pfizer and Sanofi-Aventis (Le Plessis Robinson, France). But Pfizer reached an agreement with Sanofi-Aventis earlier this month to obtain the worldwide rights to the inhaled insulin product.

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