FDA Panel Will Probe Lung Effects of Inhaled Insulin

[Northerner]

In advance of Tuesday’s hearing on MannKind Corporation’s inhaled insulin, the US FDA has outlined several safety and efficacy issues of potential concern that it will ask its Endocrinologic and Metabolic Drugs Advisory Committee to address, leading up to a vote on approval.

The product, Technosphere inhaled insulin system (Afrezza), consists of a premeal insulin powder loaded into a cartridge for oral inhalation. The company is seeking an indication as an ultra-rapid-acting insulin for adults with type 1 or 2 diabetes. In type 1 patients, the indication would be for use with injected basal insulin.

Briefing documents from both MannKind Corporation and the FDA were posted Friday on the FDA website.

According to MannKind Corporation, the inhaled insulin, which is composed of recombinant human insulin and an inert excipient, has a more rapid onset and shorter duration of action than current injectable insulins, and therefore "more closely mimics mealtime endogenous insulin secretion."

However, the FDA has declined to approve two previous versions of the product that used different inhalers (in 2010 and 2011).

http://www.medscape.com/viewarticle/822809

(free registration)

 

[heasandford]

But have you read any of the follow-up to this?

My favourite US onine Diabetes Mag supports Afrezza as an ultra-fast insulin -
http://diatribe.org/sites/default/files/diaTribe-62.pdf

see what Forbes has to say, serously scary -
http://www.forbes.com/sites/greatsp...mannkind-tanks-with-afrezza-facing-fda-d-day/
about as negative as it gets?

 

[AlisonM]

Wow! That Forbes article is some rant. It gives one furiously to think. I still have the same reservations I had when Afrezza was first mentioned though. Having extensive experience of inhalers over the years, I doubt the system's ability to deliver the precise amounts of insulin required. Inhalers by their very nature are a bit hit and miss, dependent on the users ability to get their aim exactly right each time.

And that doesn't even begin to address the fact that Afrezza itself isn't exactly a wonder drug, the research I've seen seems to highlight its utter mediocrity. Maybe it's all been a vast April Fool's prank?

 

[heasandford]

thanks for responding. I'm just taken in by the 'ultra-fast' moniker - anything that gets there faster is on my list of must-haves!
I read everyone's posts on here and frequently despair at the results I get - I now have a pump and am still getting wide variations in BGs with the same foods. I test very frequently, check results and eat a very healthy diet, I have a food science degree. I suppose the one thing I have resisted is low carbs as I just don't want to replace carbs with calories from protein or fat. Still can't get my SD lower than 3.7 (average since started pump)
Sorry, my rant over! Didn't mean to take over this thread, but usually Diatribe provides a balanced view of US issues.