FDA approves inhaled amikacin for non-tuberculous lung infection

WASHINGTON – The FDA has approved the inhalation suspension of insamed amikacin liposomes (Arikayce) for a limited population of patients with some type of non-tuberculous mycobacterial lung infection, said the agency today.

In what has been described as the first drug approved by the FDA under the Population Limit Program for Antibacterial and Antifungal Drugs, the agency has approved Arikayce for the treatment of lung diseases caused by Mycobacterium avium complex (MAC) for patients who do not respond to conventional treatment.

The Population Limited Way for Antibacterial and Antifungal Drugs was established under the 21st Century Cures Act and FDA Commissioner Scott Gottlieb discussed the need to develop drugs to treat resistant infections.

"This path, advanced by Congress, aims to stimulate the development of drugs targeting infections that lack effective therapies," he said in a statement. "We see a lot of interest among sponsors to use this new path, and we hope that it will further stimulate the development and approval of antibacterial drugs for the treatment of serious or life-threatening infections in limited populations of non-cancer patients." the needs. "

The FDA also noted that the drug has been approved under the accelerated approval procedure, which is reserved for drugs "for serious or life-threatening diseases where it is shown that the drug has an effect reasonably likely to predict clinical benefit for patients. "

A meeting of the FDA Advisory Committee in August voted to approve treatment as part of combined antibacterial therapy in patients with few or no treatment options. As part of the expedited approval process, the safety and efficacy of the drug was based on tests conducted using a proxy assessment criterion – three successive cultures of negative sputum. The committee also voted against recommending treatment in all patients with this type of lung disease.

Arikayce will have a warning boxed on the increased risk of respiratory diseases, such as hypersensitivity pneumonitis, bronchospasm, exacerbation of underlying pulmonary diseases and hemoptysis, said the official. ;agency.

2018-09-28T18: 08: 25-0400