MannKind is a giant step closer to bagging a US green light for its inhaled diabetes therapy Afrezza (insulin human), after winning favour with regulatory advisors.
Shares in the group surged close to 80% in the morning as investors revelled in news that, following two previous rejections by the US Food and Drug Administration, things are looking good for a 'third time lucky' approval.
The FDA's Endocrinologic and Metabolic Drugs Advisory Committee voted 13 to one that Afrezza Inhalation Powder should be authorised to improve glycaemic control in adults with type I diabetes, and unanimously supported its approval for patients with the type II form.
Afrezza is a drug-device combination product, consisting of an inhalation powder delivered using a small, discreet and easy-to-use inhaler.
Administered at the start of a meal, the powder dissolves immediately upon inhalation to the deep lung and delivers insulin quickly to the bloodstream, with peak levels achieved within 12 to 15 minutes of administration, compared to 45-90 minutes for injected rapid acting insulin analogs and 90-150 minutes for injected regular human insulin.
If approved, the treatment would be the first ultra rapid-acting mealtime insulin therapy available in the US, giving patients another option for controlling blood sugar levels.
However, Simos Simeonidis, an analyst at Cowen & Co, expressed surprise at the panel's positive recommendation and noted there could still be a few hurdles ahead for the therapy.
Despite an overwhelmingly positive outcome in terms of vote, the panel's tone was a lot more ominous, with discussions focusing on Afrezza's "modest efficacy" and "serious safety concerns".
"We continue to view commercialisation as a significant challenge, especially in light of what we expect to be a label with a number of restrictions (i.e. at least no smokers, no patients with asthma or COPD)," he said, adding that "assuming it is approved, we expect MannKind and its potential partner(s) would have to conduct a fairly extensive post-marketing set of studies, aimed at addressing the product’s safety concerns, mainly around lung function and lung cancer".