MannKind resubmits Afrezza to the FDA

On October 14, MannKind announced the resubmission of Afrezza, its ultra-rapid-acting inhaled insulin, to the FDA. The FDA had previously issued a complete response letter in January 2011 asking for additional information before Afrezza could be approved. Unless the FDA delays the review, a decision on whether to approve the drug is expected by April 15, 2014. When a company gets a “complete response letter” it means the product has not been approved and the letter delayed Afrezza by nearly three years. Now that it has been submitted again with new data, we are hopeful that this time it will be approved.

Taken at meal time, Afrezza is an ultra-rapid-acting insulin that peaks in 12-15 minutes. The resubmission to the FDA includes the two recently completed phase 3 trial results for Afrezza that showed several benefits for people with type 1 and type 2 diabetes – a lower A1c (superior to placebo in type 2, non-inferior to Novolog in type 1), improvements in fasting glucose (type 1 and type 2), less hypoglycemia (type 1), and less weight gain (type 1). The trial did not reveal any serious safety concerns, and the most common side effects were a mild cough during the first few weeks of treatment, which means there will likely be a contraindication for people who smoke, have asthma, or have other respiratory issues. For more details on the trial results, read our new now next in diaTribe #57. We don’t’ know if “time in zone” was measured; unfortunately, at the time these trials were ongoing, the newer CGM systems were not available, so the sensors were less accurate. Going forward, we hope to always see “time in zone” data as we believe it could be quite persuasive and reflects the real patient experience better than A1c.

If approved, Afrezza would be the first major advance in rapid-acting insulin since Humalog was approved in 1996; indeed, it would be the first of what we consider the “ultra-rapid-acting” class. It could be particularly useful for people with type 2 diabetes who don’t want to inject insulin outside the home and for all patients who want to avoid high blood sugars after meals. Afrezza’s 12-15 minute peak is a major improvement over the typical 60-90 minute peak most patients see with the fastest insulins on the market (Humalog, Novolog, and Apidra). This should result in much better after-meal glucose control. There is also interest in using Afrezza in conjunction with an artificial pancreas, since it could overcome the challenge automated systems face in controlling post-meal glucose spikes. A study is currently ongoing at the Sansum Diabetes Research Institute. –NL/AB/KC