Mannkind’s inhaled insulin Afrezza edges closer to market
Mannkind will re-submit its inhaled insulin Afrezza for FDA approval later this year after collecting positive data from two Phase III trials.
FDA authorisation could open huge commercial possibilities for the Californian drug maker, with the inhalable insulin offering an alternative to regular injections for diabetics.
MLV & Co analyst Graig Suvannavejh told Reuters he expects Afrezza (insulin human [rDNA origin]) sales in the US and Europe to reach $3 billion by 2025, should it gain authorisation.
The product is a fast-acting powder that is inhaled before eating. It is designed to imitate conventional mealtime insulin release by reaching peak levels in less than 15 minutes.
The company’s chief executive, Alfred Mann, said: “We are pleased that both Phase III studies met their primary efficacy endpoints and [also demonstrated] comparability between the Gen2 and MedTone inhalers.”
But it has not been an easy ride for the treatment: in 2011 the FDA rejected the drug, demanding further trials to establish the effectiveness of Mannkind’s next-generation (Gen2) inhaler, Dreamboat, versus MedTone, an earlier version.
And despite much interest from pharma in the technology, extensive research into inhaled insulin has yet to produce a blockbuster.
Pfizer’s Exubera was the first product of its kind to hit the market, but failed to catch on due to its cost and bulky inhaler design, and was withdrawn in 2007.
Diabetes specialists Lilly and Novo Nordisk abandoned similar products the following year as doubts emerged about the technology’s commercial viability.
But in contrast to its predecessors’ inhalers, Dreamboat fits comfortably in the palm of the hand and bears more of a resemblance to a large USB flash drive.
Two Phase III trials were conducted on the drug which looked at Afrezza’s impact on type I and II diabetes. The data suggests that the drug significantly decreased fasting blood glucose levels in the former, and elicited superior A1c hemoglobin level reduction in the latter.
The World Health Organization estimates that nearly 350 million people have the condition globally and that it will become the world’s seventh leading cause of death by 2030.
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