The FDA’s Antimicrobial Drugs Advisory Committee voted 12 to 2 in favor of the safety and efficacy of ALIS (amikacin liposome inhalation suspension) for difficult-to-treat patients with nontuberculous mycobacterial lung disease.
A US Food and Drug Administration (FDA) advisory committee has voted 12 to 2 in favor of the safety and efficacy of ALIS (amikacin liposome inhalation suspension), a treatment for adults with nontuberculous mycobacterial lung disease caused by Mycobacterium avium complex who have few or no other treatment options.
The committee also voted that the surrogate endpoint of sputum culture conversion is reasonably likely to predict clinical benefit.
However, the committee voted against the safety and efficacy of ALIS in a broad population of patients with nontuberculous mycobacterial (NTM) lung disease caused by Mycobacterium avium complex (MAC).
The treatment is currently under FDA Priority Review with an action date set for September 28, 2018 under the Prescription Drug User Fee Act (PDUFA). If ALIS is approved, it will be the first drug specifically indicated for the treatment of patients with nontuberculous mycobacterial lung disease caused by Mycobacterium avium complex.
“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,” Will Lewis, President and Chief Executive Officer of Insmed said in a statement.
The FDA’s Antimicrobial Drugs Advisory Committee reviewed Insmed’s new drug application (NDA), which included data from the phase 3 CONVERT study.
The CONVERT study demonstrated a 29% decrease in the evidence of NTM for patients treated with ALIS and guideline-based therapy, compared to just 9% by guideline-based therapy alone at 6 months (p <0.0001).
“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,” said Paul Streck, MD, Chief Medical Officer of Insmed.
ALIS has previously received Orphan Drug and Breakthrough Therapy designations from the FDA, and has been named a Qualified Infectious Disease Product (QIDP) under the Generating Antibiotic Incentives Now (GAIN) Act.
“We look forward to working closely with the FDA as it completes its review of our application,” added Streck.