Advisory Committee recommends ALIS to treat nontuberculous mycobacterial (NTM) lung disease caused by Mycobacterium avium complex . Insmed Inc.

Insmed Incorporated has announced that the 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 III 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.

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 III 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.

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.

Comment: PDUFA date is set at 28 September 2018.