FDA Advisory Committee Votes 12-2 in Favor of the Safety and Effectiveness of Insmed’s ALIS for the Treatment of NTM Lung Disease Caused by MAC for Adult Patients with Limited or No Treatment Options
--Advisory committee supports surrogate endpoint of sputum culture conversion--
--ALIS currently under FDA Priority Review; PDUFA action date set for
“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
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
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.
About NTM Lung Disease
NTM lung disease is a rare and serious disorder associated with increased rates of morbidity and mortality. There is an increasing prevalence of lung disease caused by NTM and
The prevalence of human disease attributable to NTM has increased over the past two decades. In a decade long study (1997 to 2007), researchers found that the prevalence of NTM lung disease in the U.S. was increasing at approximately 8% per year and that NTM patients on
ALIS is a novel, inhaled, once-daily formulation of amikacin that is in late-stage clinical development and under regulatory review by the
About CONVERT (INS-212) and INS-312
CONVERT is a randomized, open-label, global Phase 3 trial designed to confirm the culture conversion results seen in
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Source: Insmed, Inc.