European Commission greenlights Insmed’s Arikayce for nontuberculous mycobacterial lung infections

pharmafile | October 29, 2020 | News story | Sales and Marketing |  Arikayce, EU, lungs, pharma 

The European Commission (EC) has given approval to Insmed Incorporated’s Arikayce (liposomal 590mg nebuliser dispersion) for the treatment of nontuberculous mycobacterial (NTM) lung infections caused by Mycobacterium avium complex (MAC).

The approval relates to adult patients without cystic fibrosis who face limited treatment options.

Phase 3 data submitted in support of the application indicated that Arikayce, when combined with multi-drug regimen (MDR), improved sputum culture conversion rates compared to MDR alone in this indication.

“Today’s approval marks a significant milestone in advancing care for patients with MAC lung disease in the EU,” said Professor Michael Loebinger, an investigator in the study, Respiratory Consultant at Royal Brompton Hospital, and Professor of Practice (Respiratory Medicine) at Imperial College London. “Currently, many patients fail to respond to the standard treatment regimen and continue to suffer from the debilitating effects of this rare and serious disease. Results from the landmark CONVERT study show that adding Arikayce has the potential to help patients who were refractory to standard treatment achieve culture conversion – a critical outcome.”

The decision follows the recommendation of the European Medicines Agency (EMA)’s Committee for Medicinal Products for Human Use in July earlier this year that the therapy be awarded approval. Furthermore, the ruling by the EMA’s Committee for Orphan Medicinal Products upheld its original 2014 opinion that the drug maintain Orphan Drug Designation in the EU.  

Insmed confirmed it would aim to launch the product in Germany first, followed by the UK and other European markets.

Matt Fellows