Arikace amikacin regulatory update

Insmed said it would need to conduct an additional Phase III trial of Arikayce amikacin to treat non-tuberculous mycobacterial (NTM) lung infection before submitting an NDA to FDA. Insmed had not given a timeframe for a potential NDA submission for the indication, but there was “some expectation” that the company could file in the U.S. with existing clinical data, according to Leerink’s Joseph Schwartz.

During a conference call, the company said the additional trial will be designed to confirm the positive culture conversion data seen in the double-blind, placebo-controlled, North American Phase II TARGET NTM (TR02-112) trial. The additional trial will focus on treatment-refractory patients with mycobacterium avium complex (MAC) NTM lung infections - a subgroup which Insmed said responded “particularly strongly” in TARGET NTM. Insmed expects to begin the trial in the “coming months,” with initial data expected by 1H16. The company said it does not believe “it will be necessary to go beyond that first interim examination before [it] can file” an NDA covering the subgroup. ...