MannKind Corporation announced that its MNKD-101 clofazimine inhalation suspension for the treatment of nontuberculous mycobacterial (NTM) lung infections has been granted Fast Track designation by the FDA. MNKD-101 had already received orphan drug and qualified infectious disease product (QIDP) designations.
The FDA recently cleared MannKind’s IND for the Phase 3 ICoN-1 trial of MNKD-101. That trial, which is expected to begin in June 2024, will evaluate the inhalation suspension in patients with nontuberculous mycobacterial (NTM) lung infections caused by Mycobacterium avium complex (MAC).
MannKind CEO Michael Castagna commented, “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. We are looking forward to the progression of the ICoN-1 study as well as an expedited review with a rolling submission.”
Read the MannKind Corporation press release.
