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(R) (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
program."
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(R) (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 minutes.
"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 who smoke.
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.
BOXED 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.
CONTRAINDICATIONS
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.
ADVERSE REACTIONS
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 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, 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.
CONTACT: Investors:
Matthew Pfeffer
Chief Financial Officer
MannKind Corporation
[email protected]
(661) 775-5300
Media:
Laura de Zutter
MCS Healthcare Public Relations
[email protected]
(908) 234-9900