NDA for Novel Amikacin Inhalation Submitted for Rare Lung Infection
Insmed announced the submission of its New Drug Application (NDA) for ALIS (amikacin lipsome inhalation suspension) for the treatment of adults with nontuberculous myobacterial (NTM) lung disease caused by Mycobacterium avium complex (MAC).
ALIS is a once-daily, inhalation formulation of amikacin. The efficacy of parenteral amikacin solution is already established for various susceptible infections but this novel formulation aims to avoid possible adverse toxicity associated with intravenous administration. The Company's pulmonary liposome technology uses charge neutral liposomes to deliver amikacin directly to the lung where it is taken up by the lung macrophages to the site of NTM infection. This results in a sustained release of amikacin while reducing systemic exposure and associated toxicities.
The NDA submission included data from the Phase 3 CONVERT (INS-212) study and the Phase 2 TR02-112 study. CONVERT is a randomized, open-label, global trial (N=350) intended to confirm the culture conversion results seen from the Phase 2 clinical trial conducted among patients with refractory NTM lung disease caused by MAC.The primary endpoint is the proportion of patients who achieve sputum culture conversion in the ALIS plus guideline-based therapy (GBT) group vs GBT alone by Month 6. Patients who achieve culture conversion by Month 6 will continue in the study for an additional 12 months of following the first monthly negative sputum culture; those who do not culture convert will have the option to enroll in the INS-312 Study .
The Food and Drug Administration (FDA) has 60 days to review the ALIS to determine if it is acceptable for filing. ALIS has previously been designated orphan drug status, breakthrough therapy status, and a Qualified Infectious Disease Product.
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