Insmed announced that the FDA has accepted the company’s sNDA to expand the use of Arikayce amikacin liposome inhalation suspension for the treatment of Mycobacterium avium complex (MAC) lung disease. Arikayce is delivered by PARI‘s Lamira nebulizer. According to Insmed, the agency granted priority review of the sNDA and set a PDUFA date of January 28, 2027.
The FDA originally approved Arikayce for the treatment of NTM lung disease caused by MAC in patients who had limited or no alternative treatment options in 2018. The new sNDA, which is supported by data from the Phase 3 ENCORE trial of Arikayce plus azithromycin and ethambutol in patients with newly diagnosed MAC lung infections, could extend the use of the inhalation suspension to more patients.
Insmed says that it is also looking to meet with Japanese regulators about a label expansion by the end of this year. The Japanese PMDA approved Arikayce for the treatment of MAC lung disease in patients with limited or no treatment options in 2021,
Insmed Chief Medical Officer Martina Flammer commented, “The FDA’s acceptance of this application marks a pivotal moment in our ambition to change the treatment paradigm for MAC lung disease. MAC lung disease is progressive; the longer the infection persists, the greater the damage to lung tissue and the harder it becomes to treat. If full approval is granted, Arikayce could reach patients earlier in their disease course, including those newly diagnosed or facing recurrent infections. We look forward to engaging with the FDA throughout the review process.”
Read the Insmed press release
