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 (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:
- 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
need for appropriate dose titration
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:
- A pooled analysis of seven studies demonstrated slightly
greater declines in pulmonary function (FEV1) in those treated with
Afrezza compared with comparator treatments (oral antidiabetic
medications or insulin therapy) during the first three months
(approximately 30 to 40 mL difference)
- After three months, the change 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 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
- Abstract #100B - Technosphere® Insulin Inhalation Powder (TI)
Displays Earlier Onset and Shorter Duration than 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 with T1DM
- Abstract #931P - Technosphere Inhaled (TI) Human Insulin has a
More Rapid Onset of Action Than Subcutaneous Insulins - Meta
Analysis of Clamp Data From Three Clinical Studies
- Abstract #975P - A Population PK/PD Model of Technosphere
Insulin Administered to Healthy Subjects
- Abstract #937P - Effects of Inhaled Technosphere Insulin (TI)
on the Pulmonary Function of Patients with T1D and T2D
- Abstract #973P -The Impact of Baseline Lung Function on
Outcomes With Inhaled Technosphere Insulin
ABOUT DIABETES
MELLITUSCurrently, diabetes mellitus affects 29.1 million
people in the United States, according to the Centers for
Disease Control and Prevention. Diabetes mellitus is characterized
by the body's inability to regulate levels of blood glucose
properly. Insulin, a hormone produced by the pancreas, normally
regulates the body's glucose levels, but in people with diabetes
mellitus insufficient levels of insulin are produced or the body
fails to respond adequately to the insulin it produces. In patients
with diabetes, current injected insulins are absorbed into the
bloodstream slower than the body's own insulin would be released if
the pancreas was healthy.iii
INDICATIONPrescription
Afrezza® (insulin human) Inhalation Powder is a rapid-acting
inhaled insulin used to treat adults with diabetes for the control
of high blood sugar.
LIMITATIONS OF USEDo not use
Afrezza as a substitute for long-acting insulin; Afrezza must be
used in combination with long-acting insulin in patients with type
1 diabetes.
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
- Acute bronchospasm has been observed in patients with asthma
and COPD using Afrezza.
- Afrezza is contraindicated in patients with chronic lung
disease such as asthma or COPD.
- Before initiating Afrezza, perform a detailed medical history,
physical examination, and spirometry (FEV1) to identify potential
lung disease in all patients.
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.Please see full Prescribing Information 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 be used, as
prescribed by a health care professional, in combination with other
diabetes medications to achieve target blood sugar levels. For
Afrezza doses exceeding 12 units, patients may use a combination of
4-unit, 8-unit and 12-unit cartridges. The disposable inhaler can
be used for up to 15 days, should be kept in a clean, dry place
with the mouthpiece cover on and may be wiped with a clean, dry
cloth if needed.
ABOUT MANNKIND
CORPORATIONMannKind Corporation (Nasdaq:MNKD) (TASE:MNKD)
focuses on the discovery and development of therapeutic products
for patients 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 information about MannKind. Interested persons can
subscribe on the MannKind website to e-mail alerts that are sent
automatically when MannKind issues press releases, files its
reports with the Securities and Exchange Commission or posts
certain other information to the website.
FORWARD-LOOKING STATEMENTSThis
press release contains forward-looking statements that involve
risks and uncertainties, including statements regarding MannKind's
ability to directly commercialize Afrezza and the commercial
potential ofAfrezza. 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, without limitation, completing and
analyzing the results of clinical studies, difficulties or delays
in obtaining regulatory feedback or concurrence with regulatory
authorities on the interpretation of study results, the ability to
generate significant product sales for MannKind, MannKind's ability
to manage its existing cash resources or raise additional cash
resources, stock price volatility and other risks detailed in
MannKind's filings 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.
____________________________
i http://www.diabetes.org/living-with-diabetes/treatment-and-care/medication/insulin/insulin-basics.html
ii https://archinte.jamanetwork.com/article.aspx?articleid=1835360
iii http://www.niddk.nih.gov/health-information/health-topics/Diabetes/your-guide-diabetes/Pages/index.aspx
Company Contact:
Rose Alinaya
SVP, Finance
661-775-5300
ralinaya@mannkindcorp.com
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