MannKind Corporation (NASDAQ:MNKD): Inhaler Gets FDA Panel Approval

by James Karedelli | Wednesday, Apr 2, 2014 | 1886 views

Boston, MA, 04/02/2014  (usastockreports)- The Food and Drug Administration (FDA) advisory penal has recommended MannKind Corporation (NASDAQ:MNKD)’s inhaled diabetes drug for approval. But the FDA reserves the right to adopt or decline the recommendation. The drug Afrezza is being provided as alternative to insulin injection which is currently used in the treatment of diabetes. The FDA will make its decision regarding the fate of the drug this month.

Panel vote

The Advisory panel voted 13 against 1 to recommend that Afrezza be approved for treatment of Type 1 diabetes. In another vote, the entire panel vote supported the approval of the drug for the treatment Type 2 diabetes which is a more common type. According to the advisory panel, MannKind Corporation (NASDAQ:MNKD) has demonstrated the efficacy of the drug. The panel also observed that the drug presents a better alternative to the common insulin injection treatment. Nonetheless, some panel members raised issued over the potential risks of the drug, but it seems such issues can be addressed in the labeling of the medicine.

 A journey of seven years

Winning the approval of FDA for its inhaled diabetes treatment has been nothing less than excruciating pain for MannKind Corporation (NASDAQ:MNKD). The FDA has twice turned down request to approve the drug, with the most recent rejection coming in 2011 during which MannKind switched inhalers at the time of review.

In the latest move, MannKind Corporation (NASDAQ:MNKD) hopes that it will be able to end the seven-year wait to bring a product onto the market. If the drug wins approval, experts assert, it could fetch about $583 million for the company in 2018. Shares of MannKind Corporation (NASDAQ:MNKD) declined during trading Monday as investors feared that the FDA advisory panel would return a negative verdict. Tuesday trading was halted in advance as the panel met.

Competition and opportunity

Should FDA approve MannKind Corporation (NASDAQ:MNKD)’s Afrezza for sale, the next headache will be to compete for market share with Humalog from Eli Lilly and Novolog from Novo Nordisk, both of which are insulin injections. Humalog generated $2.6 billion in sales last year, while Novolog returned $3 million from sales last year.

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