According to Insmed, the EMA’s Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion regarding approval of the company’s Arikayce nebulized liposomal amikacin for the treatment of non-tuberculous mycobacterial (NTM) lung infections caused by Mycobacterium avium complex (MAC) in patients who do not have cystic fibrosis.
According to Insmed, CHMP’s recommendation is based on data from the Phase 3 CONVERT study. Insmed originally submitted an MAA to the EMA in 2014, prior to initiation of a Phase 3 study and then withdrew that MAA in 2016. In 2018, the FDA approved Arikayce for the treatment of NTM lung infections caused by MAC in US patients who have few or no other options for treatment.
Insmed Chairman and CEO Will Lewis said, “Today’s positive opinion from the CHMP marks an important step in our journey to transform the way MAC lung disease is managed for patients around the world. If approved by the EC, Arikayce would be the first therapy in both the European Union and the United States for patients with this chronic, debilitating condition. We look forward to potentially bringing Arikayce to appropriate patients in Europe as quickly as possible.”
Read the Insmed press release.
