US regulators want inhaled insulin eyed for risks

[TalonRider]

Issue 24 Q3 2005

US regulators want inhaled insulin eyed for risks

By Lisa Richwine

WASHINGTON (Reuters) - U.S. regulators want Pfizer Inc.'s inhaled insulin powder to be scrutinized by an advisory panel for any adverse effects on the lungs or blood sugar levels, documents released on Wednesday show.

Exubera is being developed with Sanofi-Aventis and Nektar Therapeutics, and is due to be reviewed by an FDA advisory panel on Thursday.

Some analysts project it may generate sales of as much as $2 billion a year if it goes to market.

Like injectable insulin, Exubera may push blood sugar levels too low, which can cause fainting and other side effects, and some Exubera patients also experienced a decline in lung function that may be reversible, the FDA staff said.

"The prospect of being able to use insulin while avoiding some... or all... of the injections historically part and parcel of insulin therapy stands to appeal to many patients, family members and physicians," wrote Dr. David Orloff, director of the FDA's division of metabolic and endocrine drug products.

"It is essential that we and they understand the benefits and risks of this novel drug-device combination," Orloff said.

In a separate summary on the FDA's Web site, Pfizer said Exubera was "well-tolerated and safe" for diabetic adults and that risks would be explained on the product's label.

Some analysts said they had been expecting a review of Exubera's safety, and saw no major surprises in the FDA's preliminary analysis.

"Based on the summary, it seems to indicate Pfizer did demonstrate that Exubera was safe and efficacious," said A.G. Edwards & Sons analyst Albert Rauch, adding that he expected a positive recommendation for Exubera from the FDA panel.

The FDA usually follows the advice of its panels.

(Additional reporting by Bill Berkrot in New York)

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