MannKind Receives U.S. FDA Fast Track Designation for Clofazimine Inhalation Suspension for the Treatment of Nontuberculous Mycobacterial (NTM) Lung Disease
May 06 2024 - 6:05AM
MannKind Corporation (Nasdaq: MNKD), a company
focused on the development and commercialization of innovative
inhaled therapeutic products and devices for patients with
endocrine and orphan lung diseases, announced today that the U.S.
Food and Drug Administration (FDA) has granted Fast Track
designation of Clofazimine Inhalation Suspension (MNKD-101) for the
treatment of nontuberculous mycobacterial (NTM) lung disease. Fast
track designation is intended to facilitate the development, and
expedite the review, of medicines to treat serious conditions and
fill an unmet medical need.
“We are pleased with the FDA’s decision to grant Fast Track
designation for Clofazimine Inhalation Suspension, providing us an
opportunity to accelerate our efforts to potentially bring an
important medicine to patients living with NTM,” said Michael
Castagna, PharmD, Chief Executive Officer of MannKind Corporation.
“We are looking forward to the progression of the ICoN-1 study as
well as an expedited review with a rolling submission.”
ICoN-1 is a multi-national, randomized, double-blind,
placebo-controlled trial to evaluate the efficacy and safety of
Clofazimine Inhalation Suspension when added to guideline-based
therapy in adults with refractory NTM lung disease caused by
Mycobacterium Avium Complex (MAC), followed by an open-label
extension. This single registrational study anticipates getting
underway in June 2024 in the U.S., and internationally in the
second half of 2024.
The U.S. FDA previously designated Clofazimine Inhalation
Suspension as both an orphan drug and a qualified infectious
disease product (QIDP) for the treatment of pulmonary NTM
infections. A drug that receives orphan drug exclusivity receives
seven years of exclusivity, and one that also earns QIDP
designation, may receive an additional five years of market
exclusivity.
Pulmonary NTM infection is recognized as a major global health
concern due to its rising prevalence worldwide, association with
shortened life span and significant impact on patients’ daily
living. NTM is a group of bacteria naturally found in our
environment, including water and soil, that can lead to cough,
fatigue, a reduction in lung function, and poor quality of life.
While most people are exposed to NTM daily, the organisms generally
do no harm. Individuals with underlying conditions such as COPD,
asthma, and bronchiectasis are prone to NTM getting established in
the lungs, creating an infection and progressive worsening of lung
function.
NTM lung disease is more common in women over the age of 65,
with a predominance in those of Caucasian and Asian descent. In
2022, there were approximately 122,000 and 159,000 patients living
with NTM in the U.S. and Japan, respectively, with as much as 20%
of those cases being refractory. The disease state is on the rise,
with an estimated annual growth rate averaging 8%.
About MannKindMannKind Corporation (Nasdaq:
MNKD) focuses on the development and commercialization of
innovative inhaled therapeutic products and devices to address
serious unmet medical needs for those living with endocrine and
orphan lung diseases.
We are committed to using our formulation capabilities and
device engineering prowess to lessen the burden of diseases such as
diabetes, nontuberculous mycobacterial (NTM) lung disease,
pulmonary fibrosis, and pulmonary hypertension. Our signature
technologies – dry-powder formulations and inhalation devices –
offer rapid and convenient delivery of medicines to the deep lung
where they can exert an effect locally or enter the systemic
circulation, depending on the target indication.
With a passionate team of Mannitarians collaborating nationwide,
we are on a mission to give people control of their health and the
freedom to live life.
Please visit mannkindcorp.com to learn more, and follow us on
LinkedIn, Facebook, X or Instagram.
Forward-Looking StatementsThis press release
contains forward-looking statements about the initiation of a
clinical study and a planned regulatory submission that involve
risks and uncertainties. Words such as “believes”, “anticipates”,
“plans”, “expects”, “intends”, “will”, “goal”, “potential” and
similar expressions are intended to identify forward-looking
statements. These forward-looking statements are based upon
MannKind’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 various risks and
uncertainties, which include, without limitation, the risk that
continued testing of an investigational drug product may not yield
successful results or results that are consistent with earlier
testing, and other risks detailed in MannKind’s filings with the
Securities and Exchange Commission, including its Annual Report on
Form 10-K for the year ended December 31, 2023 and subsequent
periodic reports on Form 10-Q and current reports on 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.
MNKD-101 is an investigational product that is not approved for
any use in any country.
MANNKIND is a registered trademark of MannKind Corporation.
For MannKind:
Christie Iacangelo, Corporate Communications
(818) 292-3500
Email: media@mannkindcorp.com
Rose Alinaya, Investor Relations
(818) 661-5000
Email: ir@mannkindcorp.com
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