Ionis Gets FDA Fast-Track Designation for Zilganersen in Alexander Disease
By Colin Kellaher
Ionis Pharmaceuticals has won Food and Drug Administration fast-track designation for its zilganersen drug candidate for the ultra-rare neurological condition Alexander disease.
Ionis on Tuesday said there are currently no approved treatments for people living with Alexander, a progressive and ultimately fatal disorder.
The FDA's fast-track program is designed to facilitate the development and expedite the review of treatments for serious or potentially life-threatening illnesses with high unmet medical needs.
Ionis said it expects topline data from a pivotal study of zilganersen in the second half of 2025.
Write to Colin Kellaher at colin.kellaher@wsj.com
(END) Dow Jones Newswires
October 01, 2024 07:47 ET (11:47 GMT)
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