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Nextletol〡 a new cholesterol-fighting drug called Esperion, was approved by the FDA on February 21 this year to assist in the treatment of hetero-family hypercholesterolemia (HeFH) and atherosclerotic cardiovascular disease (ASCVD).
The first daily oral non-statin cholesterol-lowering drug approved by the FDA in nearly 20 years is a new mechanism for reducing LDL-C, the active ingredient of bempedoic acid, an ATP citric acid lysate (ACL) inhibitor that lowers LDL-C by lowering cholesterol biosynthetics and raising LDL lipolys.
Esperion now aims to push the fight to its direct rival, PCSK9 Monoantigen.
PCSK9 is a pre-protein-converting enzyme, oxalolytic 9, which binds to low-density lipoprotein lipolyser (LDLR) to reduce the liver's ability to remove LDL-C from the blood.
PCSK9 single anti-drug is expensive.
Amgen's Reabian (product name: Repatha, generic name: Eloyo single resistance, evolocumab), which went on sale in 2015 for $14,523 a year, Sanofi and Pralu of Regeneration Alirocumab went on sale in 2015 for $14,300 a year, and by the end of 2018 and early 2019, both drugs had been cut to $5,850 a year to promote sales.
advantage of Nexletol is the price, which is $10 a day, or $3,650 per year, below the above-mentioned Repatha and Praluent prices.
in March, just a month after Nexletol was approved, Esperion released data showing that the drug significantly reduced inflammatory protein levels in patients with abnormally high triglyceride levels (a 42 percent reduction at 12 weeks), regardless of whether the patient was actively taking standard statins.
Now, Esperion has access to new clinical data, and according to an analysis presented Friday at a virtual meeting of the American Heart Association, Esperion's Nexletol lowers bad cholesterol levels compared to placebos, and after 12 weeks of administration, Nexletol lowers cholesterol by 26.5 percent compared to the placebo group, both groups are safe.
in a separate analysis of male and female patients with cardiovascular disease, women's cholesterol levels were reduced by 21.2 percent after taking the drug, while cholesterol levels were reduced by 17.4 percent in men, regardless of abnormally high cholesterol levels.
A case that Nexletol's clinical effectiveness can be matched by PCSK9's single resistance, it is confident that the future market outlook will be bright, with market analysts expecting sales of $1.8 billion in 2026, with lower prices coupled with the convenience of oral dosing.