MannKind Receives U.S. FDA Fast Track Designation for Clofazimine Inhalation Suspension for the Treatment of Nontuberculous Mycobacterial (NTM) Lung Disease
MannKind (MNKD) has received Fast Track designation from the FDA for Clofazimine Inhalation Suspension for the treatment of NTM lung disease. This designation aims to speed up the review process for important medicines addressing unmet medical needs. The company is optimistic about the ICoN-1 study and the potential benefits for patients with NTM. The drug has also received orphan drug and QIDP designations, potentially providing up to 12 years of market exclusivity.
Fast Track designation from the FDA accelerates the review process for Clofazimine Inhalation Suspension.
The ICoN-1 study aims to evaluate the efficacy and safety of the drug in adults with refractory NTM lung disease.
Clofazimine Inhalation Suspension has received orphan drug and QIDP designations, providing potential market exclusivity of up to 12 years.
NTM lung disease is a major global health concern with a rising prevalence and significant impact on patients' lives.
The annual growth rate of NTM cases is estimated to be around 8%, indicating a growing healthcare burden.
Insights
DANBURY, Conn. and WESTLAKE VILLAGE, Calif., May 06, 2024 (GLOBE NEWSWIRE) -- 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
About MannKind
MannKind 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 Statements
This 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.
FAQ
What is the Fast Track designation MNKD received from the FDA?
MannKind received Fast Track designation from the FDA for Clofazimine Inhalation Suspension (MNKD-101) for the treatment of NTM lung disease. This designation aims to expedite the review process of important medicines addressing unmet medical needs.
What is the ICoN-1 study and when will it start?
The ICoN-1 study is a multi-national trial to evaluate the efficacy and safety of Clofazimine Inhalation Suspension in adults with refractory NTM lung disease. The study is set to commence in June 2024 in the U.S. and later in the second half of 2024 internationally.
What designations has Clofazimine Inhalation Suspension received?
Clofazimine Inhalation Suspension has been designated as both an orphan drug and a qualified infectious disease product (QIDP) for the treatment of pulmonary NTM infections. These designations may provide up to 12 years of market exclusivity.
What is the prevalence of NTM lung disease and who is most affected?
In 2022, there were approximately 122,000 and 159,000 patients living with NTM in the U.S. and Japan, respectively, with a significant portion of cases being refractory. The disease is more common in women over 65, particularly of Caucasian and Asian descent.
Why is NTM lung disease a concern?
NTM lung disease is a growing global health concern due to its rising prevalence, association with shortened life span, and impact on patients' daily living. The disease can lead to cough, fatigue, reduced lung function, and poor quality of life.
