The FDA has approved Insmed’s amikacin liposome inhalation suspension for the treatment of nontuberculous mycobacterial (NTM) lung disease caused by Mycobacterium avium complex (MAC) in a limited population of patients. Arikayce, which Insmed had recently been referring to as ALIS, is delivered using PARI’s Lamira nebulizer system. According to Insmed, Arikayce will be available to a limited number of pharmacies within a few weeks.
The FDA accepted the NDA in May 2018, and in August, the agency’s Antimicrobial Drugs Advisory Committee (AMDAC) voted in favor its efficacy and safety for patients with limited or no other treatment options. The FDA had granted orphan drug, breakthrough therapy, and QIDP designations to ALIS.
Arikayce’s label will include a Boxed Warning regarding increased risk of respiratory problems such as hypersensitivity pneumonitis, bronchospasm, exacerbations of lung disease, and spitting up blood. Insmed will also conduct an additional clinical study aimed at supporting expanded use of Arikayce to all patients with NTM lung disease caused by MAC.
Insmed President and CEO Will Lewis commented, “The approval of Arikayce is a significant moment for adult patients suffering from MAC lung disease who have limited or no available treatment options. It also represents an incredible milestone for our company, which has taken this medicine from concept to approval and now will launch the drug across the US. Our mission is to address the unmet needs of patients with serious and rare diseases, and we are thrilled to be able to provide the first-ever approved therapy specifically for patients in the US. with MAC lung disease. I want to thank the patients and physicians who have made this milestone possible through their participation in the clinical trials, as well as our dedicated Insmed team. We look forward to focusing our efforts on the launch of Arikayce in the US.”
FDA Commissioner Scott Gottlieb commented, “As bacteria continue to grow impervious to currently available antibiotics, we need to encourage the development of drugs that can treat resistant infections. That means utilizing novel tools intended to streamline development and encourage investment into these important endeavors. This approval is the first time a drug is being approved under the Limited Population Pathway for Antibacterial and Antifungal Drugs, and it marks an important policy milestone. This pathway, advanced by Congress, aims to spur development of drugs targeting infections that lack effective therapies. We’re seeing a lot of early interest among sponsors in using this new pathway, and it’s our hope that it’ll spur more development and approval of antibacterial drugs for treating serious or life-threatening infections in limited populations of patients with unmet medical needs.”
Read the Insmed press release.
Read the FDA press release.
