GNFT - Esperion's Approval And Other News: The Good Bad And Ugly Of Biopharma
Esperion Gets FDA Nod for Nexletol
Esperion Therapeutics (ESPR) reported that its lead drug candidate Nexletol has been approved by the FDA for lowering LDL-C in adults with heterozygous familial hypercholesterolemia or established atherosclerotic cardiovascular disease. The treatment has been approved for its use as an adjunct to diet and maximally tolerated statin therapy. Nexletol is the first oral, once-daily, non-statin LDL-C lowering medicine approved since 2002 for the indication.
Esperion supported its application with the data from its Nexletol clinical program. The program comprised four late stage trials where the drug showed 18 percent