29 March 2018 - ALIS previously designated as an orphan drug, breakthrough therapy and qualified infectious disease product.

Insmed Incorporated today announced that it has submitted its new drug application for ALIS (Amikacin Liposome Inhalation Suspension) to the U.S. FDA for adult patients with Nontuberculous Mycobacterial (NTM) lung disease caused by Mycobacterium avium complex (MAC).

"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 U.S. 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," remarked Will Lewis, President and Chief Executive Officer of Insmed. "We look forward to continuing our conversations with the FDA during this process."

The Company anticipates receiving a six-month Priority Review and that the NDA will be reviewed by the Division of Anti-Infective Products. The FDA will have 60 days to review the submission of the NDA to determine if it is complete and acceptable for filing. The FDA has previously designated ALIS as an orphan drug, a breakthrough therapy and a Qualified Infectious Disease Product (QIDP) under the Generating Antibiotic Incentives Now (GAIN) Act.

Read Insmed press release