The EC has granted marketing authorization to Insmed’s Arikayce nebulized lipsomal amikacin for the treatment of nontuberculous mycobacterial (NTM) lung infections caused by Mycobacterium avium complex (MAC) in adult patients without cystic fibrosis who have limited treatment options, Insmed said. In the US, the FDA approved Arikayce for the treatment of NTM lung infections caused by MAC for patients who have few or no other options for treatment in 2018.
According to Insmed, the approval 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 July 2020, the EMA’s Committee for Medicinal Products for Human Use (CHMP) recommended approval of Arikayce for this indication.
The company said that the first European launch of Arikayce will be in Germany, with launches in the UK and other EU countries to follow, “subject to local reimbursement processes.” Insmed noted that the EMA’s Committee for Orphan Medicinal Products has recommended that Arikayce keep its orphan designation for the treatment of NTM lung disease.
Insmed Chair and CEO Will Lewis said, “We are thrilled that for the first time, non-CF patients with NTM lung infections caused by MAC in the European Union (EU) have an approved therapy to help manage this difficult-to-treat condition, providing a new approach for those who have suffered with few, or no, treatment options. Today’s approval underscores our commitment to serving the MAC lung disease community around the world, and we look forward to bringing Arikayce to appropriate patients in the EU.”
Read the Insmed press release.
