Press release
Insmed Initiates Frontline Clinical Trial Program for ARIKAYCE® (amikacin liposome inhalation suspension) in Patients with MAC Lung Disease
--First Patient Dosed in Post-Marketing Program Intended to Support Full FDA Approval of ARIKAYCE and sNDA in Newly Diagnosed Patients-- --Program Includes
About this update from Insmed Incorporated
[{"type":"text","content":"--First Patient Dosed in Post-Marketing Program Intended to Support Full FDA Approval of ARIKAYCE and sNDA in Newly Diagnosed Patients--\n --Program Includes ARISE and ENCORE: Two Inter-Related Studies Conducted in Parallel--\n\n\nBRIDGEWATER, N.J., Jan. 4, 2021 /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 first patient was dosed in late December, 2020, in the frontline clinical trial program of ARIKAYCE® (amikacin liposome inhalation suspension) in patients with nontuberculous mycobacterial (NTM) lung disease caused by Mycobacterium avium complex (MAC). The program consists of ARISE, an interventional study designed to validate cross-sectional and longitudinal characteristics of patient-reported outcome (PRO) tools in MAC lung disease, and ENCORE, a pivotal trial designed to establish, using the PRO tools validated in the ARISE trial, the clinical benefits and evaluate the safety of ARIKAYCE in patients with newly diagnosed MAC lung disease. \nARIKAYCE was granted accelerated approval by the U.S. Food and Drug Administration (FDA) in September of 2018 for the treatment of MAC lung disease as part of a combination antibacterial drug regimen for adult patients who have limited or no alternative treatment options. It is the first and only therapy approved in the U.S. for the treatment of MAC lung disease. The frontline clinical trial program is intended to fulfill the FDA's post-marketing requirement to allow for full approval of ARIKAYCE in the U.S. and to support a supplemental new drug application (sNDA) for the use of ARIKAYCE as a frontline treatment for patients with MAC lung disease. \n\"We are very pleased to initiate the frontline clinical development program for ARIKAYCE, potentially laying the groundwork for a new standard of care for patients with MAC lung disease,\" said Martina Flammer, M.D., MBA, Chief Medical Officer of Insmed. \"ARIKAYCE has already changed the treatment landscape of refractory MAC lung disease since its FDA approval more than two years ago, and we are excited to build on that foundation with the initiation of these studies. Our hope is that this program will not only provide pivotal data for ARIKAYCE in a frontline setting, but also will validate PRO t...