Now Includes New Data Regarding Rapid
Onset of Activity and Duration of Effect
MannKind Corporation (Nasdaq:MNKD) (TASE:MNKD)
today announced that the U.S. Food & Drug Administration (FDA)
has approved an update to the Afrezza prescribing information to
include new clinical data that was presented at the American
Diabetes Association's 76th Scientific Sessions in June 2016.
Afrezza (insulin human) inhalation powder is approved by the FDA to
improve glycemic control in adult patients with type 1 and type 2
diabetes mellitus. It is the only inhaled rapid-acting mealtime
insulin available in the United States. Afrezza is dosed at the
beginning of a meal and begins to appear in the blood in
approximately one minute¹.
Key highlights of the label
update:
- Inclusion of study data that describe the time-action profile
by dosage strength, showing first measurable effect starts in
approximately 12 minutes, peak effects occur approximately 35 to 45
minutes after dosing and return to baseline after approximately 1.5
to 3 hours for the 4 and 12 unit cartridges respectively.
- Clarity on “Starting” and “Adjusting” mealtime dose.
- Updated pregnancy and lactation section to conform to current
FDA label guidance.
"These data articulate the rapid-acting nature
of Afrezza to address post-prandial hyperglycemia, setting it apart
from other mealtime options available to help patients maintain
greater control over their blood glucose levels,” said Satish Garg,
MD, MBBS, DM — Barbara Davis Center for Diabetes (BDC) – University
of Colorado.
Details of the label
update:
1) Clinical Pharmacology (Section 12): The basis
of this label change comes from a randomized, controlled,
six-treatment, crossover dose-response study comparing Afrezza to
the rapid-acting insulin analog, lispro, in 30 patients with type 1
diabetes. The data highlighted below demonstrates the importance of
understanding the time to peak effect and time for effect to return
to baseline.
Parameter for Insulin Effect of Available Cartridge Forms |
AFREZZA 4 units |
AFREZZA 12 units |
Time to first measurable effect |
~12 minutes |
~12 minutes |
Time to peak effect |
~35 minutes |
~45 minutes |
Time for effect to return to baseline |
~90 minutes |
~180 minutes |
2) Dosage and Administration (Section 2): The
Dosing Information section has been updated with
“Step 1” to inform how patients on injected mealtime insulin should
initially be dosed on Afrezza (Figure 1). Additionally, “Step 2”
was added to highlight that mealtime dose adjustments may be
required based on the individual metabolic needs and glycemic
control goals.
Figure
1. Mealtime AFREZZA
Starting Dose Conversion
Table http://www.globenewswire.com/NewsRoom/AttachmentNg/a5a2ad6d-6e61-4d82-bc5d-7d22c5a1f2c3
3) Use in Specific Populations (Section 8): The
Pregnancy and Lactation sections
of the label have been updated to conform to the current FDA label
guidance. These areas have been configured to provide healthcare
providers with clearer risk benefit information for informed
decision making in these populations.
In conjunction with the approved labeling
revision, MannKind received a letter of Fulfillment of
Post-Marketing Requirements for PMR 2166-2 and PMR 2166-3,
satisfying two of the four post-marketing requirements for Afrezza
as described in the 2014 FDA approval letter.
“Available data suggests approximately 70% of
people living with diabetes on insulin are not at HbA1c goals of
<7% ²,” said Michael Castagna, Chief Executive Officer, MannKind
Corporation. “We firmly believe that in order for patients to
achieve better HbA1c goals, control of mealtime glucose spikes is
critical. This label update supports Afrezza as a unique
fast-acting mealtime insulin that provides doctors and patients
with the flexibility necessary to help them achieve glycemic
control.”
About Afrezza Available by
prescription, Afrezza® (insulin human) inhalation powder is a
rapid-acting inhaled insulin indicated to improve glycemic control
in adult patients with diabetes mellitus. Afrezza was studied
in over 60 different clinical trials evaluating >3,000 people
living with type 1 and type 2 diabetes. Afrezza is covered by many
national and regional insurance plans and MannKind offers a savings
card that reduces the copay for most commercially insured patients
to as little as $15. Afrezza is the only inhaled rapid-acting
insulin available today. The inhaled route of delivery is a
unique feature that can spare patients from multiple daily mealtime
injections, but the true benefit of Afrezza is defined by its rapid
time-to-measurable-effect, time-to-peak, and return-to-baseline,
all of which allow patients the ability to experience the
management of their disease in a different way.
About MannKind
Corporation MannKind Corporation (NASDAQ:MNKD)
(TASE:MNKD) focuses on the development and commercialization of
inhaled therapeutic products for patients with diseases such as
diabetes and pulmonary arterial hypertension. MannKind is currently
commercializing Afrezza® (insulin human) inhalation powder, the
Company's first FDA approved product, in the United States, where
it is available by prescription from pharmacies nationwide.
MannKind is headquartered in Westlake Village, California, and has
a state-of-the-art manufacturing facility in Danbury, Connecticut.
The Company also employs field sales and medical representatives
across the U.S. For further information, visit
www.mannkindcorp.com.
ABOUT DIABETES
MELLITUSCurrently, diabetes mellitus affects over 30
million people in the United States, according to
the Centers for Disease Control and Prevention3. 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.
REFERENCES (1) Data on file,
MannKind Corporation (MKC-TI 142) (2) Selvin et al. Diabetes Care
2016; 39: e33-e35. (3) Centers for Disease Control and Prevention.
National Diabetes Statistics Report, 2017. CDC website.
https://www.cdc.gov/diabetes/pdfs/data/statistics/national-diabetes-statistics-report.pdf.
Accessed September 2017.
INDICATION Prescription
Afrezza® (insulin human) inhalation powder is a rapid acting
inhaled insulin indicated to improve glycemic control in adult
patients with diabetes mellitus.
LIMITATIONS OF USE Afrezza is not a substitute
for long-acting insulin; Afrezza must be used in combination with
long-acting insulin in patients with type 1 diabetes.
Afrezza is not recommended for the treatment of
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 chronic lung
problems such as asthma or COPD. Do not use Afrezza during a low
blood sugar reaction (hypoglycemia). If you are allergic to regular
human insulin or any of the ingredients in Afrezza, do not use
Afrezza as this may cause a significant and severe allergic
reaction.
Before using Afrezza, your healthcare provider
will take a medical history and do a physical exam and a breathing
test (called spirometry) because Afrezza can cause a decline in
lung function. Your healthcare provider will also want to test your
breathing 6 months after starting Afrezza, and then each year after
that.
Tell your doctor if you currently have lung
cancer or have had it in the past.
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
healthcare provider'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. Symptoms of low blood sugar include dizziness or
light-headedness, sweating, confusion, headache, blurred vision,
slurred speech, shakiness, fast heartbeat, anxiety, irritability or
mood change, hunger. Before you start using Afrezza, talk to your
healthcare provider about low blood sugar and how to manage it.
Tell your doctor about all medicines you take,
including prescription and over-the-counter medicines, vitamins or
herbal supplements. Taking certain diabetes pills called TZDs
(thiazolidinediones) with Afrezza can cause heart failure even if
you have never had heart failure or heart problems before. If you
already 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.
FORWARD-LOOKING
STATEMENTS This press release contains
forward-looking statements that involve risks and uncertainties,
including statements regarding MannKind's ability to promote
Afrezza and the therapeutic 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, without
limitation, the 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, 2016 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.
Company Contact:Rose Alinaya
SVP, Investor Relations818-661-5000 ir@mannkindcorp.com
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