FDA Advisory Committee recommends approval of Afrezza®, MannKind Corporation’s investigational drug to treat diabetes

Publicado por en 5 Abr, 2014 en Noticias | Sin comentarios

FDA Advisory Committee recommends approval of Afrezza®, MannKind Corporation’s investigational drug to treat diabetes
Afrezza® is a first-in-class, ultra rapid-acting mealtime insulin therapy being developed to improve glycemic control in adults  with Type 1 and Type 2 diabetes mellitus. It is a drug-device combination product, consisting of AFREZZA Inhalation Powder single use dose cartridges, and the small, discreet and easy-to-use Afrezza inhaler.
MannKind Corporation announced last Apr 01, 2014, that the Endocrinologic and Metabolic Drugs Advisory Committee of the U.S. Food and Drug Administration (FDA) 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,» said Alfred Mann, Chairman and Chief Executive Officer of MannKind Corporation. «We look forward to working with the FDA as they complete their evaluation of Afrezza®. 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.»

The FDA is not bound by the Advisory Committee’s recommendation but will consider its guidance in reviewing the New Drug Application (NDA) that was submitted for AFREZZA. The Prescription Drug User Fee Act (PDUFA) date for the FDA to complete its review of AFREZZA is April 15, 2014.

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