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Esperion Wins FDA Approval for First Heart Medicine, Nexletol

Feb. 21, 2020, 7:30 PM

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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