Boston, MA, 04/07/2014 (usastockreports) – MannKind Corporation (NASDAQ:MNKD), a Valencia, California based biopharmaceutical company has waited for almost seven long years to get Afrezza approved. Afrezza if approved will be Mannkind’s first commercial drug to hit markets. Afrezza is a pre-meal rapid acting insulin dose for diabetics which can be inhaled. Afrezza can get peak insulin levels within 12 to 15 minutes of inhalation, as the drug delivers insulin rapidly in to bloodstream. Company is marketing a device called Dreamboat to inhale this rapid acting inhalable insulin medicine. The drug has been rejected twice by FDA, and is up for approval for the third time. FDA is expected to come out with decision by April 15, 2014.
Two rejections for Afrezza
MannKind Corporation (NASDAQ:MNKD) has waited for seven years and got two complete response letters with FDA rejecting the drug approval for Afrezza. For the first rejection FDA cited that Mannkind has used two different generations of Medtone inhalers for studies. FDA said that more study and testing are required to validate bioequivalence of two different inhalers used. Rejection was very obvious that time as FDA has this street rule for all medicines up for approval.
In the second complete response letter the reason for rejection was similar to reason of rejection for first time. This time Mannkind used latest generation of Medtone inhaler along with Dreamboat inhaler device which is marketed by Mannkind itself. For the second time also Mannkind’s Afrezza was not approved because of using two different inhalers in same study.
Third Time with FDA
For the third time company did it right and used only Dreamboat inhalers for the study. The inhaler has shown positive results and compared to insulin company has shown; significantly less hypoglycaemia; decrease in A1c levels not inferior to insulin aspart.
Endocrinology and Metabolic Advisory Committee of FDA has given positive recommendation for Afrezza. Alfred Mann, MannKind Corporation (NASDAQ:MNKD)’s chairman and chief executive officer, said – “We are pleased with the Advisory Committee’s approval recommendation in support of Afrezza, and we appreciate the thoroughness of their review.” According to Bloomberg average estimates drug can generate revenue of over $500 million by year 2018. While Graig Suvannavejh, Head of healthcare research at MLV & Co., said Afrezza can be a dominant player to turn over injected insulin market and could achieve peak sales of $3 billion.