FDA Advisory Committee Meeting on Inhaled Liposomal Amikacin

NTMir Applauds FDA Advisory Committee’s Decision to Recommend Approval of Arikayce (Inhaled Liposomal Amikacin)

NTM Info & Research (NTMir), the national nonprofit organization advocating on behalf of patients with nontuberculous mycobacterial (NTM) lung disease, applauds Insmed for recognizing the unmet need of patients with NTM lung disease and working tirelessly to bring a new treatment option to them.

We are thankful for the U.S. Food & Drug Administration Antimicrobial Drugs Advisory Committee’s decision on August 7th, 2018 to recommend approval of Arikayce, an inhaled liposomal amikacin treatment for Mycobacterium avium complex disease in patients who have limited or no treatment options. Today’s vote represents a major victory for patients, and for the physicians and researchers who have worked for so long to help them.

Patients have expressed a clear desire for more effective treatments with less toxic side effects, and have been asking for more inhaled therapies to treat the infection without causing harm to the rest of their bodies. This is a major step forward for inhaled antibiotic development to treat respiratory infections, and we are grateful to Insmed for their dedication to bringing this new treatment option to fruition.

While the final decision rests with the FDA’s Division of Anti-Infective Products, we are optimistic that the division will follow the committee’s recommendation, which comes after a lengthy review and robust discussion of the data and results from the clinical trials.