Wednesday, June 18, 2014 7:47:39 AM
8k :
Item 8.01. Other Events.
Insmed Incorporated (the “Company”) announced today that the U.S. Food and Drug Administration (the “FDA”) granted ARIKAYCE™, or liposomal amikacin for inhalation, Breakthrough Therapy Designation for the treatment of adult patients with nontuberculous mycobacterial (NTM) 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.
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