Insmed Inc. said a committee of the U.S. Food and Drug Administration voted 12 to 2 in favor of the safety and effectiveness of its medicine ALIS to treat patients with a type of lung disease and who have limited or no treatment options.
ALIS, or amikacin liposome inhalation suspension, which has been designated as an orphan drug and a breakthrough therapy, is aimed at treating adult patients with nontuberculous mycobacterial lung disease — a rare infection that can damage the lungs — caused by a group of bacteria known as mycobacterium avium complex that affect people with a weak immune system.
The Antimicrobial Drugs Advisory Committee's recommendation was based on data from the company's new drug application for ALIS that included data from the phase 3 Convert study, which showed that the addition of ALIS to standard treatment resulted in a reduction of bacterial density in 29% of the 336 adult patients enrolled.
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 the bacteria mycobacterium avium complex.
Bridgewater, N.J.-based Insmed said the FDA's Antimicrobial Drugs Advisory Committee voted in favor of the surrogate goal of sputum culture conversion used in a phase 3 trial, which is likely to predict clinical benefit.
The FDA is not bound by the committee's recommendation but takes its input into consideration when approving a drug.
Insmed said the FDA is expected to take a decision on the company's application for the drug by Sept. 28.