Bio pharmaceutical company Insmed Incorporated (INSM) Thursday announced orphan drug designation from the U.S. Food and Drug Administration Office of Orphan Products Development for ARIKACE, its Iiposomal amikacin for inhalation, for the treatment of infections caused by non-tuberculous mycobacteria or NTM.
Looking ahead, Will Lewis, President and CEO of Insmed said, "NTM is a chronic, debilitating disease, and currently available treatments have shown limited efficacy and tolerability. We continue to enroll patients in our phase 2 clinical trial of ARIKACE to treat NTM patients in the U.S. and Canada and look forward to having top-line data by the end of this year."
Orphan drug designation provides certain exclusivity benefits, tax credits for certain research and a waiver of the New Drug Application user fee.
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