MannKind Announces Late-Breaking Data Demonstrating Faster Onset and Shorter Duration of Action Compared to Mealtime Insulins
Data presented at ADA show Afrezza has a 25-to 35-minute faster onset of action than Lispro, with a duration that is up to two hours shorter
MannKind Corporation reaffirms commitment to Afrezza, the only inhaled insulin available in the U.S., in advance of product relaunch in July
NEW ORLEANS, June 12, 2016 (GLOBE NEWSWIRE) -- MannKind Corporation (Nasdaq:MNKD) (TASE:MNKD) today announced results of two late-breaking posters and four additional analyses of Afrezza® (insulin human) Inhalation Powder, including three posters demonstrating a faster onset of action and a shorter duration than rapid-acting insulin analogs in patients 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 improve glycemic control in adult patients with type 1 and type 2 diabetes mellitus, is the only 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 with type 1 diabetes was presented as a late-breaking poster. Results for doses matched to provide the same GIR-AUC (activity parameter) demonstrated:
Similar results were presented in Poster# 975-P and in a separate meta-analysis of three open-label clamp trials (Poster #931-P) comparing the onset of action of Afrezza with that of subcutaneous Lispro or regular human insulin, which showed onset of action (time to 10% GIR-AUC 0-240) with Afrezza was faster at 25 to 34 minutes compared to 53 to 60 minutes with Lispro.
These data highlight the faster onset of action of Afrezza compared with subcutaneous insulins is relevant for optimal dosing, and supports Afrezza's use for rapidly controlling elevated glucose levels.
Many people with type 1 diabetes and progressed type 2 diabetes inject rapid-acting insulin analogs to address rising blood sugar levels caused by food.i Hypoglycemia, a dangerous condition that occurs when blood sugar levels drop too low, can be a concern when the effects of rapid-acting insulin analogs extend past mealtime and food absorption. Insulin-related hypoglycemia resulted in nearly 100,000 hospital visits per year in the U.S. between 2007 and 2011, with a cost of $600 million during that five-year period.ii
"When administering an inhaled rapid-acting insulin or an injectable rapid-acting insulin analog, it is critical to strike the balance of providing prandial glucose control while minimizing the risk for post-prandial hypoglycemic events," said Raymond W. Urbanski, MD, PhD, Chief Medical Officer of MannKind. "These data show Afrezza begins to work in the body more rapidly and leaves the bloodstream more quickly than an injectable rapid-acting insulin analog, which could translate into more flexibility in the timing of administration and a lower potential for hypoglycemic episodes following meals."
Additional data presented in Poster #100-LB shed 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 faster 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 approximately the same insulin exposure as 3.1 IU Lispro.
"There can be significant variability in the way individuals respond to any insulin treatment, often resulting in difficulty 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 important in helping physicians understanding how to dose and titrate Afrezza in order to maintain optimal insulin response and glucose control."
Two additional analyses looking at pulmonary function tests from 4,271 patients (Posters #937-P and #973-P) showed that baseline FEV1, a common measure of lung function, was not correlated with the proportion of patients experiencing hypoglycemia, reporting cough or reaching A1C targets with Afrezza. The analyses also showed:
"Afrezza fills an important role in the management of blood sugar for people with diabetes, and MannKind is devoted to ensuring patients who can benefit from it are aware that it is available and that their doctors are appropriately trained on how to use it," said Matthew Pfeffer, Chief Executive Officer of MannKind. "When we relaunch next month, we will be pulling from nearly two years of learnings related to patient selection, access and titration, in order to simplify the process of getting this important treatment option into the hands of individuals with diabetes."
MannKind recently reacquired the rights to Afrezza and will be launching its own fully integrated commercialization infrastructure along with MannKind-branded supply of the treatment in July. Patients and healthcare providers should be aware that MannKind is committed to ensuring Afrezza remains available to diabetes patients in the United States with no disruptions in access. In addition, MannKind earlier this week announced a new collaboration with JDRF to advance therapies for all patients with type 1 diabetes.
AFREZZA STUDIES PRESENTED AT ADA
ABOUT DIABETES MELLITUS
LIMITATIONS OF USE
Do not use Afrezza to treat diabetic ketoacidosis.
Afrezza is not recommended in patients who smoke or who have recently stopped smoking.
IMPORTANT SAFETY INFORMATION FOR AFREZZA
WARNING: RISK OF ACUTE BRONCHOSPASM IN PATIENTS WITH CHRONIC LUNG DISEASE
Do not use Afrezza if you have problems with your lungs, such as asthma or COPD. Do not use Afrezza during a low blood sugar reaction (hypoglycemia). If you are allergic to any of the ingredients in Afrezza, do not use Afrezza as this may cause a significant and severe allergic reaction.
Before using Afrezza, your doctor will take a medical history and do a physical exam and a breathing test (called spirometry) to determine if you have lung problems. Patients with lung problems should not use Afrezza. If your doctor finds you have lung problems, use of Afrezza may cause a severe asthma-like breathing problem. Afrezza can reduce lung function, so your doctor will also want to test your breathing 6 months after starting Afrezza, and then each year after that, with more frequent testing done if you have symptoms such as wheezing or coughing. Tell your doctor if you currently have lung cancer or have had it in the past, or if you have an increased risk of developing lung cancer.
You must test your blood sugar levels while using insulin such as Afrezza. Do not make any changes to your dose or type of insulin without talking to your healthcare provider. Any change of insulin should be made carefully and only under your doctor's care.
The most common side effect of insulin, including Afrezza® (insulin human) Inhalation Powder, is low blood sugar (hypoglycemia), which can be serious and life-threatening. Some people may experience symptoms such as shaking, sweating, fast heartbeat, and blurred vision. It may cause harm to your heart or brain. It is important for you to understand how to manage the use of Afrezza, and to understand how to lessen the risk of hypoglycemia events.
Tell your doctor about other medicines you take, especially ones commonly called TZDs (thiazolidinediones) and supplements, because they can change the way insulin works. If you have heart failure or other heart problems, it may get worse while you take TZDs with Afrezza. Before starting Afrezza, it is important to tell your doctor about all your medical conditions including if you have a history of lung problems, if you are pregnant or plan to become pregnant, or if you are breastfeeding or planning to breastfeed.
In addition to low blood sugar (hypoglycemia), other possible side effects associated with Afrezza include cough, throat pain or irritation, headache, diarrhea, tiredness, and nausea.
ABOUT MANNKIND CORPORATION
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