Insmed Submits New Drug Application to FDA for ALIS in NTM Lung Disease Caused by MAC

Insmed (Nasdaq:INSM), a global biopharmaceutical company focused on the unmet needs of patients with rare diseases, today announced that it has submitted its New Drug Application (NDA) for ALIS (Amikacin Liposome Inhalation Suspension) to the U.S. Food and Drug Administration (FDA) for adult patients with Nontuberculous Mycobacterial (NTM) lung disease caused by Mycobacterium avium complex (MAC).

As quoted in the press release:

“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.”

Click here to read the full press release.