(Bloomberg) — MannKind Corp.’s inhaled diabetes treatment has won the backing of a U.S. Food and Drug Administration (FDA) advisory panel.
FDA approves moves MannKind a step closer to getting a product on the market.
Members of the panel voted 13-1 to approve use of the drug, Afrezza, to treat Type 1 diabetes, and 14-0 to approve use of the drug to treat Type 2 diabetes.
The FDA doesn’t have to follow panel recommendations.
FDA staff raised concerns in a report March 28 that the medicine may affect lung function and questioned missing data from a study of Type 1 patients.
The FDA approved Exubera, an inhaled insulin treatment from Pfizer Inc., in 2006. Pfizer pulled its product after sales proved to be lower than hoped, according to the FDA staff report.
FDA staffers note in the report that Exubera put insulin – a growth factor that can increase the risk of cancer – directly in the lungs.
The possibility that inhaled insulin could increase the risk of lung cancer could also be concern with Afrezza, the staffers say.
MannKind has spent almost eight years trying to get the FDA to approve Afrezza since it started late-stage product trials.
“We are pleased with the advisory committee’s approval recommendation in support of Afrezza, and we appreciate th”ae thoroughness of their review,” said Alfred Mann, MannKind’s 88-year-old founder, chairman, chief executive officer and largest shareholder. “Diabetes is a major health problem in the United States, and we are committed to bring Afrezza to the many patients who might benefit from this novel product.”
Mann has said that Afrezza is different than Exubera.
An Afrezza user inhales the insulin before a meal, and the inhaled insulin works faster than injectable products, more closely mimicking natural insulin production in healthy people, MannKind says.
While some FDA advisory panel members who recommended approval expressed reservations about potential safety risks, they said MannKind demonstrated that Afrezza works.
The advisers said the benefit of an alternative to insulin injections outweighed the cancer concerns or could be addressed in the medicine’s labeling.
If approved, Afrezza may generate $534 million in revenue in 2018, based on estimates from three analysts.
The FDA could decide whether to clear the drug for sale by April 15.
–With assistance from Caroline Chen in New York.
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