Wednesday, June 18, 2014
$INSM Insmed says FDA grants breakthrough therapy designation to Arikayce
Insmed announced that the FDA granted ARIKAYCE, or liposomal amikacin for inhalation, Breakthrough Therapy Designation for the treatment of adult patients with nontuberculous mycobacterial lung disease who are treatment refractory. This designation is based on findings from the company?s U.S. phase 2 clinical trial of ARIKAYCE to treat NTM lung infections. The company has plans to meet with the FDA to discuss the regulatory pathway for ARIKAYCE, Insmed stated.