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, reports Reuters.
The FDA's Endocrinologic and Metabolic Drugs Advisory Committee is to consider whether to recommend the drug to government regulators for approval.
The FDA usually follows the recommendations of its advisory committees, but is not required to do so.
During drug trials, researchers found inhaled insulin was generally as effective as injections in controlling blood sugar levels, informs Daily Mail.