FDA advisory committees recommend approval of ultra rapid-acting mealtime insulin therapy

VALENCIA, Calif. — MannKind Corp. on Tuesday announced that the Endocrinologic and Metabolic Drugs Advisory Committee of the Food and Drug Administration voted 13-to-1 to recommend that Afrezza (insulin human [rDNA origin]) inhalation powder be granted marketing approval by the FDA to improve glycemic control in adults with Type 1 diabetes and voted 14-to-0 to recommend that Afrezza be granted marketing approval by the FDA to improve glycemic control in adults with Type 2 diabetes. 

If approved, AFREZZA would be the first ultra rapid-acting mealtime insulin therapy available in the United States.

"We are pleased with the Advisory Committee's approval recommendation in support of Afrezza, and we appreciate the thoroughness of their review," stated Alfred Mann, chairman and CEO MannKind Corporation. "We look forward to working with the FDA as they complete their evaluation of Afrezza."

 

 

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