Ionis Gets FDA Fast-Track Designation for Olezarsen in Familial Chylomicronemia Syndrome
January 31 2023 - 7:52AM
Dow Jones News
By Colin Kellaher
Ionis Pharmaceuticals Inc. on Tuesday said the U.S. Food and
Drug Administration granted fast-track designation to olezarsen for
the treatment of the genetic disease familial chylomicronemia
syndrome.
The Carlsbad, Calif., pharmaceutical company said there are
currently no approved therapies in the U.S. for the treatment of
the disease, which is characterized by severely high levels of
plasma triglycerides and a risk of unpredictable and potentially
fatal acute pancreatitis.
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, which last year completed enrollment in a Phase 3 study
of olezarsen in adults with familial chylomicronemia syndrome, said
it plans to share data from the study in the second half of
2023.
Write to Colin Kellaher at colin.kellaher@wsj.com
(END) Dow Jones Newswires
January 31, 2023 07:37 ET (12:37 GMT)
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