--ALIS currently under FDA Priority Review; PDUFA action date set for September 28, 2018--
BRIDGEWATER, N.J., Aug. 07, 2018 (GLOBE NEWSWIRE) -- Insmed Incorporated (Nasdaq:INSM ), a global biopharmaceutical company focused on the unmet needs of patients with rare diseases, today announced that the U.S. Food and Drug Administration's (FDA) Antimicrobial Drugs Advisory Committee voted 12 to 2 in favor of the safety and effectiveness of ALIS (amikacin liposome inhalation suspension) for adults with nontuberculous mycobacterial (NTM) lung disease caused by Mycobacterium avium complex (MAC) who have limited or no treatment options. The committee also voted in favor of the surrogate endpoint of sputum culture conversion used in the Phase 3 CONVERT study being reasonably likely to predict clinical benefit. If approved, ALIS will be the first and only therapy in the U.S. specifically indicated for the treatment of patients with NTM lung disease caused by MAC.
"We are very pleased by the outcome of today's advisory committee meeting, which recognized the role ALIS may be able to play in addressing the significant unmet medical need among patients suffering from NTM lung disease caused by MAC, a chronic, debilitating and potentially fatal infection," said Will Lewis, President and Chief Executive Officer of Insmed.
The advisory committee's recommendation was based on briefing materials developed from Insmed's new drug application (NDA) for ALIS, which was submitted under accelerated approval provisions and includes data from the Phase 3 CONVERT study. The study met its primary endpoint of culture conversion by Month 6 with statistical significance for once-daily ALIS when added to guideline-based therapy (GBT) compared with GBT alone in patients with refractory NTM lung disease due to MAC.
"The patients included in our Phase 3 clinical trial represent the most difficult-to-treat segment of the NTM lung disease population, having already failed treatment with current guideline-based therapy. The committee's favorable recommendation brings us one step closer to providing the first and only FDA-approved treatment for these patients. We look forward to working closely with the FDA as it completes its review of our application," said Paul Streck, M.D., Chief Medical Officer of Insmed.
In a separate vote, the committee voted against the safety and effectiveness of ALIS in the broadest population of adult patients with NTM lung disease caused by MAC.
The FDA is not bound by the committee's recommendation but takes its input into consideration when evaluating whether to approve Insmed's NDA for ALIS, which is currently under Priority Review by the FDA with an action date of September 28, 2018 under the Prescription Drug User Fee Act (PDUFA). The FDA has previously designated ALIS an orphan drug, a breakthrough therapy, and a Qualified Infectious Disease Product (QIDP) under the Generating Antibiotic Incentives Now (GAIN) Act.
About NTM Lung Disease
NTM lung disease is a rare and serious disorder associated with increased