What Does Novo Nordisk's Move Mean for Afrezza?

For most of 2015, market watchers and diabetes patients alike have observed the Afrezza conundrum: despite glowing reports from users, sales have been well below expectations, due to a number of challenges for Afrezza’s maker, MannKind, and its marketing partner, Sanofi.

Now comes a new threat: competitor Novo Nordisk has filed a new drug application (NDA) for a “faster-acting insulin aspart,” which is described as a “mealtime insulin developed for the treatment of adults with type 1 and type 2 diabetes.”

The application, filed December 9, 2015, doesn’t say just how fast that “faster acting” insulin is. It does say the insulin would be injected with Novo Nordisk’s FlexTouch device.

It remains to be seen whether Afrezza will maintain any edge over a Novo Nordisk insulin. At the moment, the company’s fastest-acting product, Novolog, takes up to 30 minutes longer to reach its peak absorption rate.

No matter what, Afrezza’s inhalable form would still have the same benefits and challenges it has now: convenience and freedom from needles for those who dislike injections. This includes the potential willingness of some type 2 patients to use insulin who won’t try it at all.

A search social media under the hashtag “Afrezza,” produces posts that say, “My lowest A1C ever,” some with printouts showing the proof. Patients with type 1 diabetes revel in enjoying a holiday meal for the first time in years. There’s also occasional discussion of what to do when an endocrinologist won’t prescribe the mealtime insulin.

Afrezza isn’t intended to replace long-acting insulin for type 1 patients; instead, it’s used at mealtimes to quickly keep blood sugar levels in check. Patients have offered testimonials about increased levels of glycemic control, as well as not drawing attention by injecting themselves in public.

Quarter earnings reports are a different story. The American Journal of Managed Care reported this summer how Sanofi made a concerted effort at the American Diabetes Association meeting in June to educate physicians on how to bill for spirometry, which FDA required to screen out patients with lung problems. Despite this, the black box warning is enough to scare off many physicians from prescribing Afrezza. A bigger problem appears to be payers, many of whom have declined to cover the therapy.