European Commission Grants Marketing Authorization for ARIKAYCE Liposomal 590 mg Nebuliser Dispersion for the Treatment of NTM Lung Infections Caused by MAC in Adult Non-CF Patients with Limited Treatment Options

— ARIKAYCE is the First and Only Therapy Approved in Both the European Union and United States for This Difficult-To-Treat Condition —

— Planned Product Launches to Begin in Germany, Followed by UK and Other EU Countries —

BRIDGEWATER, N.J., Oct. 28, 2020 /PRNewswire/ -- Insmed Incorporated (Nasdaq: INSM), a global biopharmaceutical company on a mission to transform the lives of patients with serious and rare diseases, today announced that the European Commission (EC) has granted marketing authorization for ARIKAYCE Liposomal 590 mg Nebuliser Dispersion ("ARIKAYCE") for the treatment of nontuberculous mycobacterial (NTM) lung infections caused by Mycobacterium avium complex (MAC) in adults with limited treatment options who do not have cystic fibrosis. Consideration should be given to official guidance on the appropriate use of antibacterial agents.

"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," said Will Lewis, Chair and Chief Executive Officer of Insmed. "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."

The EC approval of ARIKAYCE is based on results from the randomized, open-label, global Phase 3 CONVERT study, which demonstrated that once-daily ARIKAYCE, when combined with multi-drug regimen (MDR), improved sputum culture conversion rates in patients with refractory NTM lung disease caused by MAC compared to MDR therapy alone. The most common side effects with ARIKAYCE affecting the respiratory system are dysphonia, cough, dyspnea, and hemoptysis.

"Today's approval marks a significant milestone in advancing care for patients with MAC lung disease in the EU," said Professor Michael Loebinger, Respiratory Consultant at Royal Brompton Hospital, London, Professor of Practice (Respiratory Medicine) at Imperial College, London, and an investigator in the CONVERT study. "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."