Boston, MA 10/14/2013 (wallstreetpr) – For the sake of humanity, MannKind Corporation (NASDAQ:MNKD) which so far has no drug on the market hopes its candidate Afrezza will this time get the approval of the Food and Drug Administration (FDA).
The company on Monday announced resubmitting of new drug application to FDA for the drug candidate which might turn out to be the much needed solution for adults with diabetes.
MNKD’s Afrezza is a fast-acting inhaler insulin powder contained in cartridge delivery. First application for approval of this drug was in March 2009. But in 2011, FDA asked for further clinical study on this adult diabetes drug. The reason FDA sent Afrezza back to the manufacturer for more trial was to compare the drugs efficacy with the previous inhalers which had been submitted for approval. History shows that FDA is quite strict when it comes to approval of inhaled insulin and many drugs have fallen casualty to this strictness of the approving agency.
From 2011 when FDA returned a “further trial note” to MNKD, the drug manufacturer in August this year announced that the drug has met its two trial objectives.
In the latest Afrezza study, one set of patients around 171 were tried for type-1 diabetes and another set of around 175 patients were tried for type-2 diabetes. Therefore the new application includes data from these two successful trials, raising chances for the drug’s approval.
As more cases of obesity are linked to rise in diabetes, there is a growing demand for drugs that treat diabetes. But several drug developers have failed in their attempts with inhaled insulin for adult diabetes condition. This is why MNKD may run into good sales and profits if the drug gets the FDA nod.
The performance of MNKD shares on Monday reveals growing optimism in the stock which can be link higher belief that Afrezza will be approved this time round. MNKD has a market cap of $1.60 billion as of Monday, October 14, 2013.
