MannKind Corp has submitted a New Drug Application to regulators in the USA requesting approval of Afresa, its inhaled insulin drug.

The company is asking the US Food and Drug Administration to give the thumbs-up to the compound, an ultra rapid-acting insulin, for the treatment of adults with type 1 or type 2 diabetes for the control of hyperglycaemia. It is also looking for approval of the Afresa inhaler that delivers the powder.

A number of high-profile players – Pfizer, Eli Lilly and Novo Nordisk – have given up on inhaled insulin but Mannkind is confident of success. The NDA submission is based on 44 completed and five ongoing studies including over 5,300 patients. More than 2,450 subjects with type 1 or type 2 diabetes were randomly assigned to treatment with Afresa in the pooled controlled Phase II/III studies, while more than 450 subjects were exposed to the drug in single-dose studies.

Mannkind claims that “the extent of exposure meets the current guidance from the FDA regarding the development of therapies for the treatment of diabetes”. It added that “the feature that distinguishes Afresa from all other insulin products is not the route of administration - it is the pharmacokinetic profile”.

The drug immediately dissolves upon contact with the lung surface, releasing insulin monomers that rapidly enter the bloodstream, Mannkind said. Afresa then achieves peak insulin levels within 12-14 minutes of administration, “effectively mimicking the release of meal-time insulin observed in healthy individuals”.

Alfred Mann, Mannkind’s chief executive, says that the NDA submission “is the culmination of years of clinical research that has supported our long-held belief that Afresa will be a first-in-class ultra rapid-acting insulin with the potential to change the way diabetes is treated". It remains to be seen whether the FDA agrees but investors were pleased by the news and in after-hours trading, Mannkind shares were up 6.5% to $3.30.

Last week, Mannkind signed an agreement to acquire Pfizer’s insulin manufacturing facility in Germany.