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 ...
- NOTE: ESPR won EU approval for