MannKind Corp on Monday said it had submitted a revised application to the U.S. Food & Drug Administration to allow the company to market its inhaled diabetes drug Afrezza. The submission includes results from two additional clinical trials required by regulators.
The FDA two years ago rejected the Valencia biotech’s first application, saying the company needed to include studies on its revamped smaller inhaler, which was not part of the original application in 2009.
Afrezza delivers a fast-acting insulin powder via a proprietary inhaler, nicknamed Dreamboat. MannKind's latest filing includes data from separate studies on patients with type 1 or type 2 diabetes.
“We designed the recent studies with input and guidance from the FDA, and both achieved their primary efficacy endpoints and safety objectives,” Chief Executive Alfred Mann said in a statement. “I am very proud of our team for completing an extensive submission on a very ambitious schedule.”
MannKind shares closed up 18 cents, or 3.5 percent, to $5.29 on the Nasdaq.