Rosuvastatin/ezetimibe tablet approved for LDL reduction in hyperlipidemia, HoFH
Althera announced the FDA approved its rosuvastatin/ezetimibe tablets as an adjunct to diet for treatment of elevated LDL in adults with primary nonfamilial hyperlipidemia or homozygous familial hypercholesterolemia.
According to a press release from the company, the once-daily tablet (Roszet, Althera) contains rosuvastatin, a statin for LDL reduction, and ezetimibe, a cholesterol absorption inhibitor.
“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,” Christie M. Ballantyne, MD, chief of cardiology and cardiovascular research at Baylor College of Medicine, said in the release. “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. 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.”
Rosuvastatin/ezetimibe is available as a once-daily tablet with dosages of 5 mg/10 mg, 10 mg/10 mg, 20 mg/10 mg and 40 mg/10 mg, according to the release.
Warnings and precautions of rosuvastatin/ezetimibe tablet use include:
- rosuvastatin/ezetimibe should not be taken by patients with hypersensitivity to either component of the tablet or those with active liver failure or decompensated cirrhosis;
- rosuvastatin/ezetimibe tablets should be discontinued when pregnancy is recognized and breastfeeding during treatment is not recommended; and
- concomitant use of rosuvastatin/ezetimibe with gemfibrozil, cyclosporin and antivirals should be avoided.
"With Roszet’s approval in the U.S., we reaffirm our commitment to improving cholesterol treatment options for physicians and patients," Sanjeev Agarwal, CEO of Althera, said in the release. "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.”
Roszet will be available in pharmacies June 2021, the company stated in the release.