Bloomberg Law
Feb. 21, 2020, 7:30 PM

Esperion Wins FDA Approval for First Heart Medicine, Nexletol

Bailey Lipschultz
Bailey Lipschultz
Bloomberg News
Scott Schnipper

Esperion won FDA approval for Nexletol (bempedoic acid) to treat for the treatment of adults with heterozygous familial hypercholesterolemia or established atherosclerotic cardiovascular disease who require additional lowering of LDL-C., according to the agency’s website.

  • Drug approved in the 180mg dose; label notes the effect on cardiovascular morbidity and mortality has not been determined
  • Nexletol marks ESPR’s first U.S.-approved drug; it is expected to gain approval in combination with ezetimibe later this month; Wall Street expects 2020 sales of ~$33m
    • NOTE: ESPR won EU approval for the drug as a monotherapy as well as in combination with ezetimibe for ...

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