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# Insmed Seeking Accelerated Approval for Lung Disease Drug
- URL: https://www.fdaweb.com/insmed-seeking-accelerated-approval-for-lung-disease-drug/
- Published: 2017-09-05T12:00:00.000Z
- Updated: 2026-09-14T22:46:31.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5139543

Insmed plans to seek accelerated approval of its inhaled therapy Alis (amikacin) based on data from the CONVERT study in adult patients with treatment-refractory nontuberculous mycobacterial (NTM) lung disease caused by mycobacterium avium complex (MAC). The agency previously granted the product a breakthrough therapy designation, fast track status, and a qualified infectious disease product designation.

Just announced top-line data from CONVERT had the therapy meeting its primary endpoint of culture conversion by month six with statistical and clinical significance. “The study demonstrated that the addition of Alis to guideline-based therapy (GBT) eliminated evidence of NTM lung disease caused by MAC in sputum by month six in 29% of patients, compared to 9% of patients on GBT alone (p < 0.0001),” the company says. CONVERT enrolled 336 adult patients with NTM lung disease caused by MAC who were refractory to at least six months of GBT. “Top-line data for the secondary endpoint of time to conversion demonstrated that patients on GBT took approximately 30% longer to convert when compared to patients on Alis plus GBT (p < 0.0001),” it says.

Insmed says its advanced pulmonary liposome technology uses charge neutral liposomes to deliver amikacin directly to the lung where it is taken up by the lung macrophages. “This prolongs the release of amikacin in the lungs while minimizing systemic exposure thereby offering the potential for decreased systemic toxicities,” it says.