MannKind Corp has once again resubmitted its inhaled insulin Afrezza with the US Food and Drug Administration and a number of observers believe it could be third time lucky.
Afrezza (insulin human [rDNA origin]) has been refiled to improve glycaemic control in adults with type 1 or type 2 diabetes based on "the entire data set from the extensive Afrezza clinical development programme and particularly the positive results from two recent Phase II trials". Regarding the latter two studies, chief executive Alfred Mann noted that they were designed with input and guidance from the FDA "and both achieved their primary efficacy endpoints and safety objectives".
The Prescription Drug User Fee Act (PDUFA) date for Afrezza is now April 13 next year. The road to approval has been a rocky one, given that the FDA first rejected the drug in 2010 and turned it down again in 2011.
Simos Simeonidis, an analyst at Cowen & Co, said of Afrezza that "we think it should be approved, but we don't take approval for granted here, given FDA's history with this programme". He added that it "could be a paradigm-shifting drug" but "we also believe there is still the outside chance of a negative surprise in the form of the agency asking MannKind to jump through additional hoops".
In October 2007, Pfizer pulled its inhaled insulin therapy Exubera after it failed to make any impact in the diabetes market, while Eli Lilly and Novo Nordisk have given up on inhaled insulin programmes.