MannKind Gets FDA Fast Track for Clofazimine Inhalation for NTM Lung Disease

May 06, 2024 -- MannKind Corporation (Nasdaq: MNKD), a company focused on developing and commercializing innovative inhaled therapeutic products for patients with endocrine and orphan lung diseases, has announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to its Clofazimine Inhalation Suspension (MNKD-101) for treating nontuberculous mycobacterial (NTM) lung disease. This designation aims to speed up the development and review process for drugs addressing serious conditions with unmet medical needs.

"We are delighted with the FDA's decision to grant Fast Track designation for Clofazimine Inhalation Suspension, which allows us to accelerate our efforts to potentially provide an important treatment for patients living with NTM," said Michael Castagna, PharmD, Chief Executive Officer of MannKind Corporation. "We anticipate the advancement of the ICoN-1 study and an expedited review process, including a rolling submission."

The ICoN-1 study is a multi-national, randomized, double-blind, placebo-controlled trial designed 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 will commence in June 2024 in the U.S. and internationally in the latter half of 2024.

The FDA had previously granted Clofazimine Inhalation Suspension both orphan drug and qualified infectious disease product (QIDP) designations for treating pulmonary NTM infections. Drugs with orphan drug exclusivity receive seven years of market exclusivity, and those with QIDP designation may receive an additional five years of market exclusivity.

Pulmonary NTM infection is a growing global health concern due to its increasing prevalence, its association with a reduced lifespan, and its significant impact on patients' daily lives. NTM consists of bacteria commonly found in the environment, such as water and soil, which can lead to cough, fatigue, decreased lung function, and poor quality of life. While most individuals encounter NTM daily without adverse effects, those with underlying conditions like COPD, asthma, and bronchiectasis are more susceptible to infection, which can result in declining lung function.

NTM lung disease is more prevalent among women over the age of 65, particularly those of Caucasian and Asian descent. In 2022, approximately 122,000 and 159,000 patients were living with NTM in the U.S. and Japan, respectively, with about 20% of those cases being refractory. The incidence of NTM lung disease is increasing, with an estimated annual growth rate of 8%.

MannKind Corporation (Nasdaq: MNKD) is dedicated to developing and commercializing innovative inhaled therapeutic products and devices to address severe unmet medical needs for patients with endocrine and orphan lung diseases. The company aims to use its formulation capabilities and device engineering expertise to mitigate diseases such as diabetes, NTM lung disease, pulmonary fibrosis, and pulmonary hypertension. MannKind's technologies, including dry-powder formulations and inhalation devices, facilitate rapid and convenient delivery of medications to the deep lung, allowing for localized or systemic effects depending on the treatment's target.

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