MannKind Corporation, a leading company specializing in the development and commercialization of innovative inhaled therapeutic products and devices, has announced that its Clofazimine Inhalation Suspension (MNKD-101) has been granted Fast Track designation by the U.S. Food and Drug Administration (FDA) for the treatment of nontuberculous mycobacterial (NTM) lung disease. This designation is aimed at expediting the review and development of medicines that address serious conditions and unmet medical needs.
The Fast Track designation for Clofazimine Inhalation Suspension is a significant milestone for MannKind Corporation. It provides an opportunity to accelerate efforts in potentially bringing this important medicine to patients living with NTM, a condition recognized as a major global health concern due to its rising prevalence worldwide and its impact on patients’ daily lives.
Michael Castagna, PharmD, Chief Executive Officer of MannKind Corporation, expressed his satisfaction with the FDA’s decision, stating that the Fast Track designation will allow the company to expedite its efforts and potentially provide a much-needed treatment option for patients with NTM. He also mentioned the company’s excitement about the progression of the ICoN-1 study and the opportunity for an expedited review with a rolling submission.
The ICoN-1 study is a multi-national, randomized, double-blind, placebo-controlled trial that aims 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). The study is expected to commence in June 2024 in the U.S., followed by international sites in the second half of the year.
Clofazimine Inhalation Suspension has previously received both orphan drug and qualified infectious disease product (QIDP) designations from the U.S. FDA for the treatment of pulmonary NTM infections. Orphan drug exclusivity provides seven years of market exclusivity, and QIDP designation may grant an additional five years of exclusivity.
NTM lung disease is a condition caused by a group of bacteria found naturally in the environment, including water and soil. While most people are exposed to NTM daily without harm, individuals with underlying conditions such as COPD, asthma, and bronchiectasis are prone to developing NTM lung infections, leading to a progressive decline in lung function and a significant impact on their quality of life.
With an estimated annual growth rate of 8%, NTM lung disease is on the rise. In 2022, approximately 122,000 and 159,000 patients were living with NTM in the U.S. and Japan, respectively, with up to 20% of cases being refractory.
MannKind Corporation is dedicated to developing and commercializing innovative inhaled therapeutic products and devices to address serious unmet medical needs in endocrine and orphan lung diseases. Their signature technologies, including dry-powder formulations and inhalation devices, offer rapid and convenient delivery of medicines to the deep lung, providing localized or systemic effects depending on the target indication.
As MannKind Corporation continues its mission to improve the lives of patients living with diseases such as diabetes, NTM lung disease, pulmonary fibrosis, and pulmonary hypertension, their commitment to formulation capabilities and device engineering is poised to make a significant impact in the field of respiratory medicine.
For more information about MannKind Corporation and their innovative solutions, please visit mannkindcorp.com and follow them on LinkedIn, Facebook, Twitter, or Instagram.
Please note that MNKD-101 is an investigational product and is not approved for use in any country. MannKind is a registered trademark of MannKind Corporation.