Boston, MA 04/02/2014 (wallstreetpr) – Valencia based, MannKind Corporation (NASDAQ:MNKD) has received majority approval from an FDA panel for the use of Affreza, in the treatment of diabetes This is a major milestone for MannKind, which has been trying over the past two years to launch its first product into the market.
MannKind’s share price has gained 82% in the current trading session after investors became worried on whether the drug will get the approval from the FDA. This marked the biggest fall for the company since October 2012 as trade was stopped awaiting the big announcement.
FDA Panel Voting’s
The Food and Drug Administration voted 13 to 0 for the drug to be used for Type 1 Diabetes treatment with 14 to 0 voting for it to be approved for Type 2 diabetes. The only concern at the moment lies on the fact that some FDA staff on March 28 on a report, raised issues concerning the drugs effect on the lung function. The staff had also raised issues regarding missing data from a study on Type 1 diabetes patients.
Some panel members who had voted for the drug had also expressed reservations about potential safety risks but maintained that MannKind had demonstrated enough on the ability of the drug to work. The drug has now passed the acid test with the panel maintaining that any concerns could be addressed in the medicines labelling.
This is a huge step for MannKind Corporation (NASDAQ:MNKD) going forward as the drug had been turned by the FDA on two different occasions with the recent one being back in 2011 when the company decided to switch the drugs inhalers during the review process.
Afrezza has the potential to generate up to $583 million in annual revenue according to average estimate compiled by analysts at Bloomberg. MannKind Corporation (NASDAQ:MNKD) now awaits April 15 to see whether it has received all approval from the FDA to begin selling the drug. Affreza when fully approved will compete with Eli Lilly &Co.’s, Humalog as well as Novo Nordisk’s, Novolog which are both injected insulin’s.
The FDA is not bound by the advisory committee recommendation but is expected to take into consideration the panels results while coming out with its final verdict.