BioCentury
ARTICLE | Regulation

Learning the limits of limited use

How FDA’s LPAD pathway tipped the scales for Insmed’s Arikayce amikacin

October 26, 2018 3:16 PM UTC

While it’s too soon to tell if FDA’s limited-use pathway for anti-infectives will boost development in the underserved field, the pathway’s first approval has helped clarify the amount of uncertainty the agency is willing to accept.

On Sept. 28, FDA granted accelerated approval to Insmed Inc.’s Arikayce amikacin, an inhaled liposome suspension, to treat lung infections caused by Mycobacterium avium complex (MAC). The approval is restricted to adults who do not respond to standard of care and therefore have few or no treatment options. ...

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Insmed Inc.