MannKind Reaffirms Commitment to Afrezza; Plans Product Relaunch – SCVNEWS.com

Valencia-based MannKind Corp. announced outcomes of two late-breaking posters and four extra analyses of Afrezza® (insulin human) Inhalation Powder, including three posters demonstrating a quicker onset of action and a shorter duration compared to rapid-acting insulin analogs in patients along with diabetes mellitus. These data were presented at the American Diabetes Association’s 76th Scientific Sessions (ADA). Afrezza, approved by the FDA in 2014 to increase glycemic regulate in adult patients along with type 1 and type 2 diabetes mellitus, is the just inhaled insulin product available in the U.S.

A randomized, controlled, six-treatment, crossover dose-response study (Poster #100-LB) comparing Afrezza to the rapid-acting insulin analog, Lispro, in 30 patients along with type 1 diabetes was presented as a late-breaking poster. outcomes for doses matched to offer the very same GIR-AUC (activity parameter) demonstrated:

* Onset of action within 16 to 21 moments for Afrezza compared to 45 to 52 moments for subcutaneous insulin across studies

* Afrezza’s duration of action at clinically relevant doses was consistently shorter by 2 to 3 hours

* Afrezza’s labeled dose overestimates its effect reinforcing the requirement for correct dose titration

Similar outcomes were presented in Poster# 975-P and in a divide meta-analysis of three open-label clamp trials (Poster #931-P) comparing the onset of action of Afrezza along with that of subcutaneous Lispro or normal human insulin, which showed onset of action (time to 10% GIR-AUC 0-240) along with Afrezza was quicker at 25 to 34 moments compared to 53 to 60 moments along with Lispro.

These data highlight the quicker onset of action of Afrezza compared along with subcutaneous insulins is relevant for suitable dosing, and supports Afrezza’s usage for quickly controlling raised glucose levels.

Many individuals along with type 1 diabetes and progressed type 2 diabetes inject rapid-acting insulin analogs to treat rising blood sugar levels caused by food.i Hypoglycemia, a dangerous condition that occurs as quickly as blood sugar levels lose also low, can easily be a concern as quickly as the effects of rapid-acting insulin analogs extend past mealtime and meals absorption. Insulin-related hypoglycemia resulted in nearly 100,000 hospital visits per year in the U.S. between 2007 and 2011, along with a cost of $600 million throughout that five-year period.ii

“as quickly as administering an inhaled rapid-acting insulin or an injectable rapid-acting insulin analog, it is important to strike the balance of providing prandial glucose regulate while minimizing the risk for post-prandial hypoglycemic events,” said Raymond W. Urbanski, MD, PhD, Chief Medical Officer of MannKind. “These data reveal Afrezza begins to job in the physique a lot more quickly and leaves the bloodstream a lot more swiftly compared to an injectable rapid-acting insulin analog, which could translate in to a lot more flexibility in the timing of administration and a lesser potential for hypoglycemic episodes adhering to meals.”

extra data presented in Poster #100-LB lose light on the dosing of Afrezza relative to subcutaneous rapid-acting insulin. Though no single conversion factor could fully describe the effect, it was noted that the quicker response and shorter duration were maintained across matched dosing. As a result, investigators on the late-breaking study reinforced the importance of dose titration for each patient. Based on pharmacokinetic and pharmacodynamic data, it was observed that a 4 unit Afrezza cartridge provides roughly the very same insulin exposure as 3.1 IU Lispro.

“There can easily be considerable variability in the means people respond to any sort of insulin treatment, frequently resulting in difficulty along with dose selection or a perceived lack of response,” said Tim Heise, MD, of the Profil Institute for Clinical Research in Germany and a study investigator. “The findings presented at ADA are essential in aiding physicians learning exactly how to dose and titrate Afrezza in order to sustain suitable insulin response and glucose control.”

Two extra analyses looking at pulmonary function examinations from 4,271 patients (Posters #937-P and #973-P) showed that baseline FEV1, a common measure of lung function, was not correlated along with the proportion of patients experiencing hypoglycemia, reporting cough or reaching A1C targets along with Afrezza. The analyses likewise showed:

* A pooled analysis of seven surveys demonstrated slightly higher declines in pulmonary function (FEV1) in those treated along with Afrezza compared along with comparator treatments (oral antidiabetic medications or insulin therapy) throughout the initial three months (roughly 30 to 40 mL difference)

* After three months, the modification in pulmonary function was like comparators up to 24 months

* FEV1 reductions were small in the 2 Afrezza and comparator groups; they represented a small fraction of pulmonary capacity, and the observed treatment group difference disappeared within one month of cessation of Afrezza therapy

“Afrezza fills an essential role in the management of blood sugar for individuals along with diabetes, and MannKind is devoted to ensuring patients that can easily incentive from it are aware that it is available and that their doctors are appropriately trained on exactly how to usage it,” said Matthew Pfeffer, Chief Executive Officer of MannKind. “as quickly as we relaunch next month, we will certainly be pulling from nearly two years of learnings related to patient selection, access and titration, in order to simplify the process of obtaining this essential treatment option in to the hands of people along with diabetes.”

MannKind recently reacquired the rights to Afrezza and will certainly be launching its own fully integrated commercialization infrastructure along along with MannKind-branded supply of the treatment in July. Patients and healthcare providers must be aware that MannKind is committed to ensuring Afrezza remains available to diabetes patients in the United States along with no disruptions in access. In addition, MannKind earlier this week announced a brand-new collaboration along with JDRF to arrive therapies for every one of patients along with type 1 diabetes.