The FDA has designated the established name for Insmed’s inhaled amikacin, which is in Phase 3 development for the treatment of nontuberculous mycobacteria (NTM) lung infections, as “amikacin liposome inhalation suspension,” the company said in a business update. Insmed has previously called its amikacin suspension Arikayce and is now referring to the product as “ALIS.”
According to Insmed, plans to report topline results from the Phase 3 CONVERT study of ALIS for NTM lung infections within the next few months are on track.
Insmed President and CEO Will Lewis commented, “Throughout 2017 we have remained committed to our mission of transforming the lives of patients with rare diseases. We continue to focus on the execution and evaluation of our Phase 3 CONVERT study for which we continue to anticipate top-line results in September plus or minus one month. If the study meets the primary endpoint, we intend to complete preparation for a US regulatory filing with the FDA, under Subpart H, for the treatment of patients with refractory NTM. Our pre-commercialization activities are also accelerating, as is our assessment of the regulatory pathway beyond the US with a particular focus on Japan. We are also moving ahead with our planning for life cycle management for ALIS and advancing our pipeline.”
In June 2016, Insmed withdrew an MAA for Arikayce which it had submitted prior to the initiation of the CONVERT study.
Read the Insmed press release.