Esperion Therapeutics' Nexletol, Nexlizet Updates Get FDA Approval
14 December 2023 - 8:46AM
Dow Jones News
By Denny Jacob
Esperion Therapeutics received Food and Drug Administration
approval for updates to nexletol and nexlizet.
The pharmaceutical company said the FDA approved an updated
LDL-cholesterol lowering indication for nexletol and nexlizet to
include the treatment of primary hyperlipidemia as a qualifier for
existing approved populations.
Esperion said other changes include the maximally tolerated
qualifier for statin use has been removed, as well as the removal
of the prior limitation of use stating the effect of the two
treatments on cardiovascular morbidity and mortality has not been
determined.
The Ann Arbor, Mich.-based company said the labeling
modifications don't impact the full pending label approvals for
cardiovascular risk reduction indications for nexletol and
nexlizet, which it said remains on track for anticipated approval
in the first quarter.
Write to Denny Jacob at denny.jacob@wsj.com
(END) Dow Jones Newswires
December 13, 2023 16:31 ET (21:31 GMT)
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