Founded in 1991 by Alfred E. Mann, a medtech visionary who played a large part in the wider adoption of insulin pumps as the founder of MiniMed, the company develops Afrezza — a fast-acting insulin formulation delivered through an inhaler device.
Initially approved in 2014 as a rapid-acting inhaled insulin to improve glycemic management in adults with diabetes, the offering serves type 2 diabetes and people with type 1 diabetes who use it alongside a long-acting insulin. With recent data further supporting Afrezza, not only against the current standards of care but in the pediatric population, the company could take it even further.
Speaking with Drug Delivery Business News at the American Diabetes Association’s 85th Scientific Sessions in Chicago, MannKind Director of Medical and Scientific Engagement Joanne Rinker, MS, RDN, BC-ADM, CDCES, LDN, FADCES, explained the benefits of the inhaled insulin technology.
“It’s truly something that can improve the quality of life for people living with diabetes,” Rinker said. “If they have needle phobia, if they’re overwhelmed with technology, if they’re struggling just to get their mealtime blood sugar managed, this works quickly. … It really is a tool in the toolkit that should at least be offered as a meal time management choice for to the the person with diabetes.”
More about how Afrezza works
Inhaled insulin is simply a formulation of regular human insulin, water and a carrier — fumaryl diketopiperazine (FDKP). When inhaled, the pH changes and that causes the insulin and carrier to separate. Nearly all (99%) of the carrier is excreted in urine and the remaining 1% is excreted in stool.
The insulin is immediately inhaled through the lung, straight to the bloodstream in less than one minute. Unlike hexameric injected insulin, inhaled insulin is monomeric, allowing it to work fast.
“Inhaled insulin can quickly get to the carbohydrates that are in the bloodstream, get them into the cells and out of the bloodstream,” Rinker, who worked in a clinical diabetes care setting for more than two decades before joining MannKind, explained. “This time action profile is what makes it so so effective.”
The insulin comes in 4-, 8- and 12-unit cartridges. So, even if someone needed 16 units, they could take any combination of the cartridges to satisfy their insulin needs, one after another. Altogether, it’s packaged as Afrezza.
A key factor in Afrezza’s effectiveness, though, comes through the inhaler device.
The inhaler
Rinker said the MannKind team engineered the mechanical inhaler device to slowly bring powder into the lung. The alternative, she explained, would be essentially propelling the insulin directly into the back of the throat.
A small compartment opens for the insertion of the insulin cartridge, then the user closes it. The only other component is a mouthpiece for the sake of cleanliness. Then, the inhalation takes just two seconds. It requires no electronics or extra components.
Prescribed Afrezza users receive two inhalers that are good for 15 days, so they receive new ones every month, Rinker said.
Size-wise, MannKind managed to make the device compact and similar in size to a typical asthma inhaler. The proprietary device can fit easily into a purse or in a pocket. Plus, with the inhaled insulin powder, it enables a potentially longer shelf life for the life-saving therapeutic.
“They can stay out of the fridge and out of the foil packaging for three days,” Rinker said. “If you keep it in the foil packaging, the whole package can stay out for 10 days. It’s very heat-stable, stable outside the refrigerator, unlike [injected] insulin.”
Rinker said that it eliminates the need for someone to carry around a cooler for their insulin if they aren’t in the comfort of their home all day.
“We see a real benefit for someone like, say, a truck driver, police officer or a farm or factory worker, or something like that,” Rinker said. “Really, for just anyone in need of insulin transport flexibility.”
What need does the MannKind inhaled insulin offering satisfy?
Over the past year, MannKind has offered a range of data highlighting the performance of Afrezza against other methods of insulin delivery — including multiple daily injections (MDI), an automated insulin delivery system, (AID) or a pump without automation.
The company also shared data late last year demonstrating Afrezza’s efficacy in children aged 4-17. Rinker said the company is currently “pending submission” to the FDA. It hopes to submit within the calendar year, with a potential green light in the following year. Further data shared at this year’s ADA found Afrezza both safe and effective in that age range.
MannKind now has a focus on continuing medical education and taking part in conferences like ADA, Rinker said, which has gathered momentum for its inhaled insulin offering. That momentum is building interest and curiosity around Afrezza and could grow the understanding of its utility as an option for people with diabetes.
“We’re not claiming that everybody should be taking inhaled insulin but, if they need mealtime management, they should at least be offered inhaled insulin as a choice,” Rinker said.
According to Rinker, when it comes to insulin burden or fear when people don’t want injections, a switch from MDI to Afrezza plus a long-acting insulin, more people may be able to reach their A1C goals. MannKind reported last fall that subjects receiving Afrezza (plus degludec) achieved A1c less than 7% at 30 weeks, marking a 100% increase from baseline (21% to 42% getting to goal of 7% of less.)
“All that means is that a person can make a choice,” Rinker said. “If they’re on MDI, they know they could actually really improve. If they’re on AID, they know they could have similar outcomes if they switch to inhaled insulin. In the end, it just provides an opportunity to make a choice and I think options are the most important thing.”
