FDA Advisory Committee Recommends Approval of AFREZZA(R), MannKind Corporation's Investigational Drug to Treat Diabetes
April 01 2014 - 5:47PM
MannKind Corporation (Nasdaq:MNKD) today announced that the
Endocrinologic and Metabolic Drugs Advisory Committee of the U.S.
Food and Drug Administration (FDA) voted 13 to 1 to recommend that
AFREZZA® (insulin human [rDNA origin]) Inhalation Powder be granted
marketing approval by the FDA to improve glycemic control in adults
with type 1 diabetes and voted 14 to 0 to recommend that AFREZZA be
granted marketing approval by the FDA to improve glycemic control
in adults with type 2 diabetes. If approved, AFREZZA would be the
first ultra rapid-acting mealtime insulin therapy available in the
United States.
"We are pleased with the Advisory Committee's approval
recommendation in support of AFREZZA, and we appreciate the
thoroughness of their review," said Alfred Mann, Chairman and Chief
Executive Officer of MannKind Corporation. "We look forward to
working with the FDA as they complete their evaluation of AFREZZA.
Diabetes is a major health problem in the United States, and we are
committed to bring AFREZZA to the many patients who might benefit
from this novel product."
The FDA is not bound by the Advisory Committee's recommendation
but will consider its guidance in reviewing the New Drug
Application (NDA) that was submitted for AFREZZA. The Prescription
Drug User Fee Act (PDUFA) date for the FDA to complete its review
of AFREZZA is April 15, 2014.
About AFREZZA®
AFREZZA® (uh-FREZZ-uh) is a novel, ultra rapid-acting mealtime
insulin therapy developed by MannKind Corporation to improve
glycemic control in adult patients with type 1 or type 2 diabetes.
It is a drug-device combination product, consisting of AFREZZA
Inhalation Powder delivered using a small, discreet and easy-to-use
inhaler. Administered at the start of a meal, AFREZZA Inhalation
Powder dissolves immediately 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, compared to
45-90 minutes for injected rapid acting insulin analogs and 90-150
minutes for injected regular human insulin.
About MannKind Corporation
MannKind Corporation (Nasdaq:MNKD) focuses on the discovery,
development and commercialization of therapeutic products for
patients with diseases such as diabetes. Its lead product
candidate, AFREZZA®, is under review by the FDA. MannKind regularly
posts copies of its press releases as well as additional
information about MannKind on its website www.mannkindcorp.com.
Interested persons can subscribe on the website to e-mail alerts
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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, difficulties or
delays in obtaining regulatory feedback 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, 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.
CONTACTS: Investors:
Matthew J. 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
Jeff Hoyak
MCS Healthcare Public Relations
jeffh@mcspr.com
(908) 884-6753
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