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 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® (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
mpfeffer@mannkindcorp.com
(661) 775-5300
Media:
Laura de Zutter
MCS Healthcare Public Relations
laurad@mcspr.com
(908) 234-9900
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