Public Policy Statement | May 2024
At MannKind, we are focused on the development and commercialization of innovative inhaled therapeutic products and devices for people living with endocrine and orphan lung diseases. As part of this concentration, we are developing a novel treatment for NTM (nontuberculous mycobacteria) called Clofazimine Inhalation Suspension. NTM lung infection is considered a rare condition and MannKind is committed to studying this investigational medicine to potentially bring it to patients as quickly and equitably as possible, pending the results of the upcoming clinical trial(s).
Participation in clinical trials should be the primary route by which patients receive access to investigational medicines. These clinical trials contribute to the systematic collection of data needed to properly assess whether an investigational product is safe and effective, and they are needed to support regulatory approval(s). Achieving regulatory approval for a medicine is the optimal way long-term to provide access to life saving medicines to a broader swath of patients who may benefit around the world.
MannKind is evaluating an Expanded Access Program (EAP) to provide eligible patients with access to our investigational NTM treatment. We recognize EAPs are designed to offer a pathway for patients who have exhausted standard treatment pathways or are unable to participate in ongoing clinical trials.
MannKind is not currently accepting expanded access requests, but you are welcome to check back here for policy changes as they develop. This webpage will be updated as we continue to explore the ability to provide EAP as an option for appropriate patients.
If you have questions about this policy or would like information about how to enroll in our clinical trial(s), please contact us at: ICoN1research@mannkindcorp.com.