MannKind Corp said the U.S. Food and Drug Administration extended the review date of its inhaled insulin treatment by three months….
The news comes less than a week after an advisory panel to the FDA recommended approving the treatment, Afrezza, but said longer-term studies would be required to gauge the risk of lung cancer and other potential side-effects.
MannKind said on Monday the new review date of July 15 was set to give the FDA time to fully review information it had submitted.
Afrezza consists of a whistle-sized inhaler designed to deliver insulin powder to the lungs, making it more convenient to use than conventional injected insulin.
If approved, Afrezza would be the first inhaled insulin treatment available in the United States since 2006.
News Release Mannkind 4-8-2014