Esperion Therapeutics' Nexletol, Nexlizet Updates Get FDA Approval
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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