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Rosuvastatin/Ezetimibe Combination Therapy Approved for Lowering LDL-C

Althera Pharmaceuticals announced the FDA approved rosuvastatin and ezetimibe (Roszet) as an adjunct to diet for lowering LDL-C in adults patients with primary non-familial hyperlipidemia or homozygous familial hypercholesterolemia.

Patients with primary non-familial hyperlipidemia or homozygous familial hypercholesterolemia have a new option for reducing LDL-C thanks to the FDA approval of rosuvastatin and ezetimibe (Roszet), according to a statement from Althera Pharmaceuticals.

Approved as an adjunct to diet for the treatment of elevated LDL-C in adult patients, the oral combination therapy was shown to lower LDL-C by up to 64% and is expected to be available in pharmacies in June 2021.

“The optimal LDL-C levels in guidelines across the world have been shifting lower and now many patients need to get their LDL-C below 70 mg/dL,” said Christie Ballantyne, MD, Chief of Cardiology and Cardiovascular Research at Baylor College of Medicine, in the aforementioned statement. “These levels can be quite difficult to achieve with just a statin on top of diet and exercise. Rosuvastatin and ezetimibe have been extensively studied in combination therapy and have been shown to significantly reduce LDL cholesterol beyond the statin alone.”

A combination therapy using rosuvastatin, a high-potency HMG-CoA reductase inhibitor, and ezetimibe, a selective cholesterol absorption inhibitor, the statement from Althera Pharmaceuticals noted research from multiple studies indicate rosuvastatin and ezetimibe have the potential to reduce LDL-C by as much as 72% with the 40 mg/10 mg dose and by 64% with the 10 mg/10 mg dose.

According to the release from Althera, rosuvastatin and ezetimibe will be available in dosages of 5 mg/10 mg, 10 mg/10 mg, 20 mg/10 mg, and 40 mg/10 mg. Additionally, the release note rosuvastatin and ezetimibe is contraindicated in patients with hypersensitivity to any component of rosuvastatin and ezetimibe and in patients with active liver failure or decompensated cirrhosis.

“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. “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.”

Althera Pharmaceuticals also noted the Roszet Savings Program aims to reduce co-pays for eligible patients with commercial insurance coverage to as little as $20 per month.

“Combination therapy has been widely used in hypertension to achieve lower blood pressure targets. This new therapy provides a high efficacy statin plus ezetimibe in a single once daily pill which is a powerful new option to help get patients to the desirable LDL goal without increasing pill burden or requiring addition of injectable therapies,” added Ballantyne.