Shots:

• The approval is based on P-III FDC LDL-C lowering program assessing Nexlizet (bempedoic acid and ezetimibe) vs PBO and the safety data of Nexletol (bempedoic acid) in pivotal P-III LDL-C lowering program with the existing ezetimibe safety profile
• The P-III study resulted in lowering the LDL-C by 38% when added on to maximally tolerated statins and is well tolerated. The approval follows the approval of Nexletol (bempedoic acid) received on Feb 21- 2020 with its anticipated availability in the US in Mar’2020
• Nexlizet (PO- qd) is the first non-statin LDL-cholesterol lowering combination therapy- indicated as an adjunct to diet and maximally tolerated statin therapy for HeFH/ established ASCVD in patients requiring additional lowering of LDL-C with its expected availability in the US in July’2020

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