MannKind Corporation (Nasdaq:MNKD) today announced
that it will begin to manufacture a 12 unit cartridge strength of
AFREZZA (insulin human) Inhalation Powder to improve glycemic
control in adult patients with diabetes. The 12 unit cartridge was
approved by the U.S. Food and Drug Administration on April 17, 2015
and is expected to be launched by Sanofi in the second half of
2015.
The new dosage strength complements the existing 4 unit and 8
unit cartridges and will provide patients with another option to
receive their prescribed dose.
About Afrezza®
Afrezza® (insulin human) Inhalation Powder is used to control
high blood sugar in adults with type 1 and type 2 diabetes. The
drug-device combination product consists of a dry formulation of
human insulin delivered in a specially designed inhaler.
Administered at the beginning of a meal, Afrezza® delivers insulin
into the body through the lungs with peak insulin levels achieved
within 12 to 15 minutes. Afrezza® is available in 4-unit and 8-unit
single-use cartridges that can be combined to meet the prescribed
dose. In addition, the U.S. Food and Drug Administration (FDA)
recently approved a 12-unit cartridge strength of insulin powder
for Afrezza®. The disposable inhaler can be used to take the
cartridges for up to 15 days and does not require cleaning or
maintenance.
Sanofi and MannKind have entered into a worldwide exclusive
licensing agreement to develop and commercialize Afrezza®. Under
the collaboration agreement, Sanofi is responsible for global
commercial, regulatory and development activities.
INDICATIONS AND USAGE FOR AFREZZA® (insulin human)
Inhalation Powder
Prescription Afrezza® is a man-made rapid acting inhaled insulin
breathed through your lungs and is used to control high blood sugar
in adults with type 1 and type 2 diabetes.
Limitations of Use:
- Do not use Afrezza® in place of long-acting insulin; Afrezza®
must be used with a long-acting insulin in patients with type 1
diabetes.
- Do not use Afrezza® to treat diabetic ketoacidosis.
- It is not known if Afrezza® is safe and effective for use in
people who smoke. Afrezza® is not for use in patients who
smoke or who have recently stopped smoking (less than 6
months).
- It is not known if Afrezza® is safe and effective in children
under 18 years of age.
Important Safety Information for Afrezza®
WARNING: RISK OF SUDDEN LUNG
PROBLEMS (BRONCHOSPASMS) IN PATIENTS WITH LONG-TERM (CHRONIC) LUNG
DISEASE
- Sudden lung problems (acute bronchospasm) have been
seen in patients with asthma and COPD (chronic obstructive
pulmonary disease) using Afrezza®.
- Afrezza® is not to be used in patients
with long-term lung disease such as asthma or COPD.
- Before initiating Afrezza®, your
doctor will perform a detailed medical history, physical
examination, and a breathing test (called spirometry) to identify
potential lung problems.
Do not use Afrezza® if you have problems with your lungs, such
as asthma or COPD (chronic obstructive pulmonary disease). Do not
use Afrezza® during a low blood sugar reaction (hypoglycemia). If
you are allergic to regular human insulin or to any of the
ingredients in Afrezza®, do not use Afrezza® as this may cause a
significant and severe allergic reaction.
Before using Afrezza®, it is important to tell your doctor about
all your medical conditions, including if you have a history of
lung problems, if you smoke or have recently quit smoking, if you
are pregnant or plan to become pregnant, or if you are breast
feeding or planning to breast-feed. Tell your doctor about all
other medicines and supplements you take.
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,
even if you have no lung symptoms. More frequent testing should be
done if you have symptoms such as wheezing or coughing.
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.
There are certain serious side-effects that are
associated with the use of Afrezza®.
Severe allergic reaction (including whole body reaction) is one
of the serious side effects. Get medical help right away if you
have any signs or symptoms of a severe allergic reaction,including
a rash over your whole body, trouble breathing, a fast heartbeat,
or sweating.
Low blood sugar (hypoglycemia) is one of the most common side
effects of insulin, including Afrezza®, which can be serious and
life-threatening. Common symptoms of hypoglycemia are dizziness or
light-headedness, sweating, confusion, headache, blurred vision,
slurred speech, shakiness, fast heartbeat, anxiety, irritability or
mood change, or hunger. 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.
Lung cancer occurred in more people who were taking Afrezza®
compared to other diabetes medications. There were too few cases to
know if lung cancer was related to Afrezza®. Tell your doctor
if you currently have lung cancer, have had it in the past, or if
you have an increased risk of developing lung cancer.
Heart failure can occur if you are taking insulin together with
certain medicines called TZDs (thiazolidinediones), even if you
have never had heart failure or other heart problems. If you
already have heart failure it may get worse while you take TZDs
with Afrezza®. Tell your doctor if you have any new or worsening
symptoms of heart failure including shortness of breath, swelling
of your ankles or feet or sudden weight gain. Your treatment with
Afrezza and TZDs may need to be changed or stopped if you have new
or worsening heart failure.
Get emergency help if you have trouble breathing, shortness of
breath, fast heartbeat, swelling of your face, tongue, or throat,
sweating, extreme drowsiness, dizziness, or confusion.
While using Afrezza do not drive or operate heavy machinery
until you know how Afrezza affects you. You should not drink
alcohol or use other medicines that contain alcohol and you should
not smoke.
The most common side effects of Afrezza® include low blood sugar
(hypoglycemia), cough, sore throat, headache, diarrhea, tiredness,
and nausea.
Please see full Prescribing Information, including Boxed
WARNING, at www.afrezza.com.
Afrezza® is a registered trademark of MannKind Corporation.
About MannKind Corporation
MannKind Corporation (Nasdaq:MNKD) focuses on the discovery and
development of therapeutic products for patients with diseases such
as diabetes. MannKind maintains a website at
http://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 Statements
This press release contains forward-looking statements that
involve risks and uncertainties. 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 Company'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, MannKind's
dependency on Sanofi for commercialization of Afrezza,
manufacturing effectiveness 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, 2014 and
periodic reports on Form 10-Q and 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.
CONTACT: Company Contact:
Matthew J. Pfeffer
Chief Financial Officer
661-775-5300
mpfeffer@mannkindcorp.com
MannKind (NASDAQ:MNKD)
Historical Stock Chart
From Mar 2024 to Apr 2024
MannKind (NASDAQ:MNKD)
Historical Stock Chart
From Apr 2023 to Apr 2024