According to Virginia biotech company Insmed, the US FDA has cleared the company’s Investigational New Drug (IND) application for a Phase 3 trial of its Arikace liposomal amikacin for inhalation in nontuberculous mycobacteria lung infections. Arikace is delivered using a custom PARI eFlow nebulizer system.
Renu Gupta, Insmed’s Executive Vice President Development and Chief Medical Officer says that the company expects to have data from this trial and from a Phase 3 study of Arikace for the treatment of Pseudomonas infections in cystic fibrosis patients by the middle of 2013.
Arikace already has orphan drug status in both the US and Europe for the treatment of Pseudomonas infections in CF patients, and Insmed says it will apply for orphan status for the treatment of nontuberculous mycobacteria lung infections by the end of the year.
Read the company’s press release.
