Insmed submits NDA for ALIS for the treatment of NTM lung infections caused by MAC

Insmed has submitted an NDA for ALIS amikacin liposome inhalation suspension for the treatment of nontuberculous mycobacterial (NTM) lung infections caused by Mycobacterium avium complex (MAC), the company said.

In September 2017, Insmed announced that it would seek accelerated approval for ALIS from the FDA based on positive results from the Phase 3 CONVERT (INS-212) study. The company says that it expects to receive a 6-month priority review.

Insmed President and CEO Will Lewis commented, “We are very excited to announce the completion of this important milestone which begins the formal process of review by the FDA of our application for approval of ALIS to treat patients living with NTM caused by MAC. There are currently no approved therapies in the US to treat this disease. Our submission is supported by our pivotal Phase 3 INS-212 study conducted in subjects with refractory NTM lung disease, the completed Phase 2 study TR02-112, as well as an expanded safety database. We look forward to continuing our conversations with the FDA during this process.”

ALIS, formerly known as Arikayce, has received orphan drug, breakthrough therapy, and QIDP designations from the FDA.

In June 2016, Insmed withdrew an MAA for Arikayce it had submitted based on Phase 2 data after the EMA’s Committee for Medicinal Products for Human Use (CHMP) indicated that the Phase 2 data were insufficient for approval.

Read the Insmed press release.