FDA Approves Rosuvastatin and Ezetimibe for LDL-C Reduction

The once-daily tablet is indicated for adult patients with primary non-familial hyperlipidemia or homozygous familial hypercholesterolemia


Last week, the US Food and Drug Administration (FDA) approved oral tablet rosuvastatin and ezetimibe (Roszet) for the treatment of elevated low-density lipoprotein cholesterol (LDL-C) in adults with primary non-familial hyperlipidemia or homozygous familial hypercholesterolemia.

This approval was granted to Althera Pharmaceuticals and was based off data that showed that the diet adjunct can help patients achieve up to 72% LDC-C reduction from baseline with a 40 mg rosuvastatin/10 mg ezetimibe dose and 64% reduction with a 10 mg/10mg dose.

Currently, the LDL-C level goals for many patients are < 70 mg/dL; however, simple statin use plus diet and exercise may still be inefficient to achieve such targets.

As such, the newly approved combination therapy, which consists of a statin for LDL-C reduction (rosuvastatin) and a cholesterol absorption inhibitor (ezetimibe), has been touted to provide an efficacious means of lowering lipid levels to desired patient goals without increasing pill burden or requiring injectable medications.

"With Roszet’s approval in the U.S., we reaffirm our commitment to improving cholesterol treatment options for physicians and patients," said Sanjeev Agarwal, CEO of Althera Pharmaceuticals, in a statement. "We are on a mission to positively impact patients’ health. By making this highly effective medicine available and affordable, we hope to improve the long-term health of patients, including those with prior cardiovascular disease.”

The most frequently reported adverse reactions associated with rosuvastatin during clinical trials were headache, nausea, myalgia, asthenia, dizziness, asthenia, constipation, and abdominal pain.

As for ezetimibe used in conjunction with a statin, adverse reactions were asopharyngitis, myalgia, upper respiratory tract infection, arthralgia, diarrhea, back pain, influenza, pain in extremity, and fatigue.

Patients with active liver failure or decompensated cirrhosis are discouraged from medication usage.

Rosuvastatin and ezetimibe therapy will be available in pharmacies beginning June 2021 and will be sold as a once-daily tablet with rosuvastatin/ezetimibe dosages of 5 mg/10 mg, 10 mg/10 mg, 20 mg/10 mg and 40 mg/10 mg.

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