FDA Approves Inhaled Insulin Afrezza
Alfred Mann has been working tirelessly for the diabetes community to make a painless way to take insulin.
Mann is an entrepreneur who has invested in biotechnology since the early 1970s. He is the developer of the cardiac pacemaker and the insulin pump (MiniMed). He also established Advanced Bionics, which manufactures neuroprosthetics, namely cochlear implants. So, Alfred Mann knows a thing or two about the biotech industry. In 1991, he started MannKind Corporation, which focuses on discovery and development of products for diabetes and cancer.
But, the hurdles to get inhaled insulin through the FDA haven’t been an easy one. Afrezza was rejected three times, but the company kept plugging along even when investors pulled funding for the product.
Afrezza will actually offer flexibility that we’ve haven’t had before. The interesting thing about Afrezza is that it has the potential to be used as either inhaled or liquid insulin. JDRF also used Afrezza for part of an artificial pancreas trial. The reason JDRF was interested in Afrezza was because the artificial pancreas will require a much faster uptake than is currently on the market. In a non-diabetic pancreas, insulin uptake is almost immediate. The current hexamer-based insulin has an uptake of about 20 minutes. Afrezza is a monomer-based insulin, which has a reported uptake of 12-14 minutes.
Afrezza will have some reimbursement issues with health insurance companies, but that is not a big surprise. Pump coverage, as well as CGM coverage, can still be hurdle. I think over time, we’ll learn how to request what we need and have payers consider covering part of it.
I think astronaut Neil Armstrong summed up this victory best, "One small step for man, one giant leap for MannKind!"