According to an Insmed update, the company launched recently launched Arikayce amikacin liposome inhalation suspension for the treatment of nontuberculous mycobacterial (NTM) lung disease caused by Mycobacterium avium complex (MAC) in Japan. The Japanese Ministry of Health, Labour and Welfare approved Arikayce for that indication in March 2021.
The company also said that it is moving ahead with the first Phase 2 trial of its treprostinil palmitil inhalation powder (TPIP) in patients with pulmonary arterial hypertension (PAH), and a second Phase 2 trial in PAH patients is expected to start by the end of the year. A Phase 2 trial of TPIP in patients with pulmonary hypertension associated with interstitial lung disease (PH-ILD) is expected to begin early next year. Insmed announced positive results from a Phase 1 study of TPIP in February 2021.
Insmed Chair and CEO Will Lewis said, “Insmed made meaningful progress in the second quarter of 2021, with important achievements across our four pillars—Arikayce, brensocatib, TPIP, and translational medicine. With the launch of Arikayce just last month in Japan, the largest market for refractory MAC lung disease that we are pursuing, we’re thrilled that our lead product is now available in three major territories. We continue to enroll patients in both the Phase 3 ASPEN study of brensocatib in patients with bronchiectasis and the Arikayce frontline clinical trial program in patients with NTM lung disease in line with expectations, and we are advancing TPIP to Phase 2 development in both PAH and PH-ILD. As we carry forward learnings from the past year and a half in navigating the pandemic, we have great confidence in our ability to execute on our commercial and clinical activities around the world.”
Read the Insmed press release.