| Source: MannKind
Data presented at ADA reveal Afrezza has actually a 25-to 35-minute faster onset of action compared to Lispro, along 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., beforehand 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 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 improve glycemic manage in adult patients along 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 along with type 1 diabetes was presented as a late-breaking poster. Results for doses matched to offer the same GIR-AUC (activity parameter) demonstrated:
- Onset of action within 16 to 21 minutes for Afrezza compared to 45 to 52 minutes 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 results 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 regular human insulin, which showed onset of action (time to 10% GIR-AUC 0-240) along with Afrezza was faster at 25 to 34 minutes compared to 53 to 60 minutes along with Lispro.
These data highlight the faster onset of action of Afrezza compared along with subcutaneous insulins is relevant for optimal dosing, and supports Afrezza’s use for rapidly controlling elevated glucose levels.
Many people along 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 as soon as blood sugar levels shed too low, can easily be a concern as soon 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 soon as administering an inhaled rapid-acting insulin or an injectable rapid-acting insulin analog, it is critical to strike the balance of providing prandial glucose manage 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 much more rapidly and leaves the bloodstream much more rapidly compared to an injectable rapid-acting insulin analog, which could translate in to much more flexibility in the timing of administration and a lower potential for hypoglycemic episodes following meals.”
Additional 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 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 easily be substantial variability in the means people respond to any insulin treatment, regularly 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 necessary in aiding physicians understanding exactly how to dose and titrate Afrezza in order to sustain optimal insulin response and glucose control.”
Two additional 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 better declines in pulmonary function (FEV1) in those treated along with Afrezza compared along with comparator treatments (oral antidiabetic medications or insulin therapy) throughout the very first three months (approximately 30 to 40 mL difference)
- After three months, the adjustment in pulmonary function was similar to comparators up to 24 months
- FEV1 reductions were small in both 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 necessary role in the management of blood sugar for people along with diabetes, and MannKind is devoted to ensuring patients that can easily benefit from it are aware that it is available and that their doctors are appropriately trained on exactly how to use it,” said Matthew Pfeffer, Chief Executive Officer of MannKind. “as soon 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 getting this necessary 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 need to 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 advance therapies for all patients along with type 1 diabetes.
AFREZZA surveys PRESENTED AT ADA
- Abstract #100B – Technosphere® Insulin Inhalation Powder (TI) Displays Earlier Onset and Shorter Duration compared to Insulin Lispro (Lispro)
- Abstract #102LB –Within-Subject Variability of Insulin Exposure and Metabolic Activity Following Replicate Doses of Technosphere® Insulin Inhalation Powder (TI) in Patients along with T1DM
- Abstract #931P – Technosphere Inhaled (TI) Human Insulin has actually a much more Rapid Onset of Action compared to Subcutaneous Insulins – Meta Analysis of Clamp Data From Three Clinical Studies
- Abstract #975P – A Population PK/PD Model of Technosphere Insulin Administered to Healthy and balanced Subjects
- Abstract #937P – Effects of Inhaled Technosphere Insulin (TI) on the Pulmonary Function of Patients along with T1D and T2D
- Abstract #973P –The Impact of Baseline Lung Function on Outcomes along with Inhaled Technosphere Insulin
ABOUT DIABETES MELLITUS
Currently, diabetes mellitus affects 29.1 million people in the United States, according to the Centers for Disease manage and Prevention. Diabetes mellitus is characterized by the body’s inability to regulate levels of blood glucose properly. Insulin, a hormone created by the pancreas, normally regulates the body’s glucose levels, yet in people along with diabetes mellitus insufficient levels of insulin are created or the physique fails to respond adequately to the insulin it produces. In patients along with diabetes, current injected insulins are absorbed in to the bloodstream slower compared to the body’s own insulin would certainly be released if the pancreas was healthy.iii
INDICATION
Prescription Afrezza® (insulin human) Inhalation Powder is a rapid-acting inhaled insulin used to treat adults along with diabetes for the manage of higher blood sugar.
LIMITATIONS OF USE
Do not use Afrezza as a substitute for long-acting insulin; Afrezza need to be used in combination along with long-acting insulin in patients along with type 1 diabetes.
Do not use Afrezza to treat diabetic ketoacidosis.
Afrezza is not recommended in patients that smoke or that have actually recently stopped smoking.
IMPORTANT SAFETY Article FOR AFREZZA
WARNING: RISK OF ACUTE BRONCHOSPASM IN PATIENTS along with CHRONIC LUNG DISEASE
- Acute bronchospasm has actually been observed in patients along with asthma and COPD using Afrezza.
- Afrezza is contraindicated in patients along with chronic lung disease such as asthma or COPD.
- Before initiating Afrezza, perform a detailed medical history, bodily examination, and spirometry (FEV1) to identify potential lung disease in all patients.
Do not use Afrezza if you have actually complications along with your lungs, such as asthma or COPD. Do not use Afrezza throughout a reduced blood sugar reaction (hypoglycemia). If you are allergic to any of the ingredients in Afrezza, do not use Afrezza as this might create a substantial and severe allergic reaction.
Before using Afrezza, your doctor will certainly take a medical history and do a bodily exam and a breathing test (called spirometry) to determine if you have actually lung problems. Patients along with lung complications need to not use Afrezza. If your doctor finds you have actually lung problems, use of Afrezza might create a severe asthma-like breathing problem. Afrezza can easily reduce lung function, so your doctor will certainly likewise wish to test your breathing 6 months after starting Afrezza, and then each year after that, along with much more frequent testing done if you have actually symptoms such as wheezing or coughing. Tell your doctor if you currently have actually lung cancer or have actually had it in the past, or if you have actually an increased risk of creating lung cancer.
You need to test your blood sugar levels while using insulin such as Afrezza. Do not make any changes to your dose or sort of insulin free of talking to your healthcare provider. Any adjustment of insulin need to be made carefully and only under your doctor’s care.
The most common adverse effect of insulin, including Afrezza® (insulin human) Inhalation Powder, is reduced blood sugar (hypoglycemia), which can easily be serious and life-threatening. Some people might experience symptoms such as shaking, sweating, fast heartbeat, and blurred vision. It might create harm to your heart or brain. It is necessary for you to understand exactly how to regulate the use of Afrezza, and to understand exactly how to lessen the risk of hypoglycemia events.
Tell your doctor Concerning others medicines you take, especially ones typically called TZDs (thiazolidinediones) and supplements, because they can easily adjustment the means insulin works. If you have actually heart failure or others heart problems, it might get hold of worse while you take TZDs along with Afrezza. Prior to starting Afrezza, it is necessary to tell your doctor Concerning all your medical conditions including if you have actually a history of lung problems, if you are pregnant or strategy to become pregnant, or if you are breastfeeding or preparation to breastfeed.
In addition to reduced blood sugar (hypoglycemia), others feasible adverse effects associated along with Afrezza include cough, throat pain or irritation, headache, diarrhea, tiredness, and nausea.
Please see full Prescribing Article for Afrezza, including Boxed WARNING and www.afrezza.com.
ABOUT AFREZZA®
Afrezza is available in 4-unit, 8-unit and 12-unit single-dose cartridges of insulin powder that can easily be used, as prescribed by a good health care professional, in combination along with others diabetes medications to achieve target blood sugar levels. For Afrezza doses exceeding 12 units, patients might use a combination of 4-unit, 8-unit and 12-unit cartridges. The disposable inhaler can easily be used for up to 15 days, need to be kept in a clean, dry place along with the mouthpiece cover on and might be wiped along with a clean, dry cloth if needed.
ABOUT MANNKIND CORPORATION
MannKind Corporation (Nasdaq:MNKD) (TASE:MNKD) focuses on the discovery and development of therapeutic products for patients along with diseases such as diabetes. MannKind maintains a website at www.mannkindcorp.com to which MannKind regularly posts copies of its press releases as well as additional Article Concerning MannKind. Interested persons can easily subscribe on the MannKind website to e-mail alerts that are sent automatically as soon as MannKind troubles press releases, files its reports along with the Securities and Exchange Commission or posts certain others Article to the website.
FORWARD-LOOKING STATEMENTS
This press release contains forward-looking statements that involve risks and uncertainties, including statements concerning MannKind’s ability to directly commercialize Afrezza and the commercial potential of
Afrezza. Words such as “believes”, “anticipates”, “plans”, “expects”, “intend”, “will”, “goal”, “potential” and similar expressions are intended to identify forward-looking statements. These forward-looking statements are based upon the MannKind’s current expectations. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties, which include, free of limitation, completing and analyzing the results of clinical studies, difficulties or delays in obtaining regulatory feedback or concurrence along with regulatory authorities on the interpretation of study results, the ability to generate substantial product sales for MannKind, MannKind’s ability to regulate its existing money resources or boost additional money resources, stock rate volatility and others risks detailed in MannKind’s filings along with the Securities and Exchange Commission, including the Annual Report on Form 10-K for the year ended December 31, 2015 and subsequent periodic reports on Form 10-Q and current reports on Form 8-K. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this press release. All forward-looking statements are qualified in their entirety by this cautionary statement, and MannKind undertakes no obligation to revise or update any forward-looking statements to reflect events or circumstances after the date of this press release.
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Company Contact: Rose Alinaya SVP, Finance 661-775-5300 ralinaya@mannkindcorp.com
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