FDA Panel OKs Inhaled Insulin Drug

Despite lingering concerns about safety, a Food and Drug Administration advisory panel recommended approval of the first inhaled insulin, a drug that could make life easier for millions of people with diabetes.

Exubera could reduce or eliminate the need for insulin injections to control blood-sugar levels, a grueling ritual for diabetics. The drug, to be marketed by Pfizer Inc., is a powder that patients breathe through a 6-inch inhaler.

Despite the potential benefits, some members of the advisory panel raised questions about how the drug would affect patients suffering from respiratory infections or exposed to secondhand smoke. Several also worried about the possibility of malfunctioning inhalers and a lack of African Americans in clinical trials of the drug.

The panel, meeting in Silver Spring, Md., endorsed approval of the drug on a 7-2 vote. The FDA isn’t required to follow the advice of its panels, but it typically does.

Wall Street was watching the panel review for signs that the FDA was becoming more conservative about drug safety. The agency came under harsh criticism in Congress, where it was accused of failing to monitor safety closely enough in the case of the popular arthritis pill Vioxx. The drug was voluntarily withdrawn by Merck & Co. last fall because of cardiac risks discovered after Vioxx reached the market.

Safety concerns delayed the FDA review of Exubera for three years while Pfizer and its partner, Paris-based drug company Sanofi-Aventis, performed additional clinical trials. The studies showed that Exubera caused a slight drop in breathing capacity, but the decline was not significant and leveled off over time.

The vote seemed to ease fears that the FDA and its advisors might become too cautious.

“I think they are still going by the science and not running scared,” said Ian Sanderson, an analyst with S.G. Cowen & Co.

The panel endorsed Exubera for adults with juvenile- or adult-onset diabetes. Exubera is short-acting insulin that can be taken before meals. It would not replace long-acting insulin shots taken before bedtime. The drug’s label will warn that smokers should not use Exubera because smoking increases the effect of insulin and could cause dangerous drops in blood-sugar levels, Pfizer said.

But the panel raised issues that Pfizer would have to address in the coming weeks, analysts said. Some members of the panel called on Pfizer to develop a program that would train patients to use Exubera correctly.

“To have people rush to this product and say, ‘I can throw away insulin and syringes,’ that is not correct and needs to be emphasized more,” said panel Chairman Paul Woolf, head of the department of medicine at Crozer Chester Medical Center in Upland, Pa. He voted against Exubera.

Sanderson predicted that FDA approval would be delayed from October until next year while Pfizer and the agency addressed safety matters. Annual Exubera sales estimates range from $1.5 billion to $3 billion globally within five years. The drug is not approved for sale in Europe but soon could be.

New York-based Pfizer and Nektar Therapeutics, the San Carlos, Calif., company that invented the drug and licensed it to Pfizer, said they were pleased with the vote. Nektar started working on the drug 15 years ago.

Nektar founder John Patton said he was “terrified” by the panel’s intense questioning. During the final vote, he and others from Nektar “were pacing like guys in a delivery room.”

Pfizer said it would track 5,000 patients once the drug was approved to learn more about Exubera.

Pfizer shares rose 21 cents to $26.51, and trading in Nektar was halted.