Grandbrothers
Esperion (NASDAQ:ESPR) stock shot up 18% in late morning trading Monday in the wake of news that the FDA has broadened the labeling for its cardiovascular drugs Nexletol and Nexlizet.
Under the new labeling, the drugs are also indicated for cardiovascular risk reduction and expanded LDL cholesterol lowering in both primary and secondary patients. The expanded labeling also supports use of the drugs either alone or in combination with statins, according to Esperion.
The drugs have also been approved for the treatment of primary hyperlipidemia, either alone or in combination with a statin. Esperion added the medications are the only LDL cholesterol-lowering non-statin drugs indicated for primary prevention patients.
An EU advisory panel recommended label expansions for the drugs on March 21. Esperion expects to receive a final determination by European regulators in Q2.