MannKind Corporation Announces FDA Approval of AFREZZA(R); A Novel,
Rapid-Acting Inhaled Insulin for the Treatment of Diabetes
VALENCIA, Calif., June 27, 2014 (GLOBE NEWSWIRE) -- MannKind Corporation
(Nasdaq:MNKD) today announced that the U.S. Food & Drug Administration (FDA)
has approved AFREZZA^® (insulin human) Inhalation Powder to improve glycemic
control in adult patients with diabetes mellitus.
"Approval of AFREZZA is an important milestone for MannKind, as today's FDA
action validates the years of clinical research and commitment that powered
the development of this unique therapy," said Alfred Mann, Chief Executive
Officer, MannKind Corporation. "We are excited for patients, as we believe
that AFREZZA's distinct profile and non-injectable administration will address
many of their unmet needs for mealtime insulin therapy, and has the potential
to change the way that diabetes is treated. We thank the more than 6,500 adult
patients and healthy volunteers who participated in the AFREZZA clinical
Currently, 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.
AFREZZA^® (uh-FREZZ-uh) is a novel, rapid-acting inhaled insulin therapy
indicated to improve glycemic control in adult patients with diabetes
mellitus. The product consists of AFREZZA Inhalation Powder delivered using a
small, discreet and easy-to-use inhaler. Administered at the start of a meal,
AFREZZA dissolves rapidly upon inhalation to the deep lung and delivers
insulin quickly to the bloodstream. Peak insulin levels are achieved within 12
to 15 minutes of administration, and decline to baseline by approximately 180
"The FDA approval of AFREZZA provides healthcare professionals with an
important new safe and effective treatment option for patients with diabetes,"
said Janet McGill, M.D., Professor of Medicine at Washington University School
of Medicine. "We have seen in clinical studies that the combination of rapid
action, injection-free delivery and ease of use makes AFREZZA a welcome
alternative for many patients who require insulin."
LIMITATIONS OF USE: AFREZZA must be used in combination with a long-acting
insulin in patients with type 1 diabetes mellitus.AFREZZA is not recommended
for the treatment of diabetic ketoacidosis and is not recommended for patients
Full US Prescribing Information, including BOXED WARNING, Medication Guide and
Instructions for Use will soon be available at www.afrezza.com.Prior to the
label being posted online, a copy of the label may be requested from the
MannKind Media contacts listed at the end of this document.
AFREZZA has been approved with a Risk Evaluation and Mitigation Strategy
(REMS) required by the FDA to ensure that the benefits of AFREZZA outweigh the
potential risk of acute bronchospasm in patients with chronic lung disease.
Important Safety Information about AFREZZA (insulin human Inhalation Powder)
The following information is taken from the highlights section of the US
Prescribing Information.Please see full Prescribing Information including
BOXED WARNING:RISK OF ACUTE BRONCHOSPASM IN PATIENTS WITH CHRONIC LUNG
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.
AFREZZA is contraindicated during episodes of hypoglycemia, in patients with
chronic lung disease such as asthma or chronic obstructive pulmonary disease
(COPD), or in patients with a hypersensitivity to regular human insulin or any
of the AFREZZA excipients.
WARNINGS AND PRECAUTIONS
Acute Bronchospasm: Acute bronchospasm has been observed in patients with
asthma and COPD. Before initiating, perform spirometry (FEV1) in all
patients.Do not use in patients with chronic lung disease.
Change in Insulin Regimen:Carry out under close medical supervision and
increase frequency of blood glucose monitoring.
Hypoglycemia: May be life-threatening.Increase frequency of glucose
monitoring with changes to; insulin dosage, co-administered glucose lowering
medications, meal pattern, physical activity; and in patients with renal or
hepatic impairment and hypoglycemia unawareness.
Decline in Pulmonary Function: Assess pulmonary function (e.g., spirometry)
before initiating, after 6 months of therapy, and annually, even in the
absence of pulmonary symptoms.
Lung Cancer:AFREZZA should not be used in patients with active lung
cancer.In patients with a history of lung cancer or at risk for lung cancer,
the benefit of AFREZZA use should outweigh this potential risk.
Diabetic Ketoacidosis: More patients using AFREZZA experienced diabetic
ketoacidosis in clinical trials.In patients at risk for DKA, monitor and
change to alternate route of insulin delivery, if indicated.
Hypersensitivity Reactions: May be life-threatening. Discontinue AFREZZA,
monitor and treat if indicated.
Hypokalemia: May be life-threatening. Monitor Potassium levels in patients at
risk of hypokalemia and treat if indicated.
Fluid Retention and Heart Failure with Concomitant Use of Thiazolidinediones
(TZDs): Observe for signs and symptoms of heart failure; consider dosage
reduction or discontinuation if heart failure occurs.
The most common adverse reactions associated with AFREZZA (2% or greater
incidence) are hypoglycemia, cough, and throat pain or irritation.
About MannKind Corporation
MannKind Corporation (Nasdaq:MNKD) focuses on the discovery, development and
commercialization of therapeutic products for patients with diseases such as
diabetes. MannKind maintains a website at www.mannkindcorp.com to which
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press releases, files its reports with the Securities and Exchange Commission
or posts certain other information to the website.
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, 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, 2013 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.
Chief Financial Officer
Laura de Zutter
MCS Healthcare Public Relations
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