Sun Pharma to Launch Brillo®: an Oral Lipid-Lowering Drug
Elevated blood cholesterol is a strong atherosclerotic cardiovascular disease (ASCVD) risk factor. Many clinical trials and high-quality observational studies have documented the overwhelming cardiovascular benefits of lowering blood low-density lipoprotein cholesterol (LDL-C). Periodically, more high-quality evidence gets incorporated into evidence-based clinical practice guidelines aimed at reducing cardiovascular morbidity and mortality globally.
The 2018 American Heart Association/American College of Cardiology/Multisociety (AHA/ACC/MS) Cholesterol Guideline recommended treating LDL-C in all patients with clinical ASCVD and adults 40 to 75 years with
- diabetes,
- LDL-C≥ 190 mg/dL,
- 10-year ASCVD risk ≥20%
- 10-year ASCVD risk of 7.5% to 19.9% in the presence of risk enhancing factors or at least mild coronary artery calcium (CAC).
Statin therapy in addition to lifestyle interventions remain the cornerstone therapy for hypercholesterolemia. However, in patients with statin-associated side effects or in whom guideline-recommended LDL-C targets are not achieved despite tolerated or high-intensity statin therapy, non-statin alternatives are recommended. Bempedoic acid is one such non-statin alternative.
Bempedoic acid is a medication for treating hypercholesterolemia. It blocks an enzyme in the liver called adenosine triphosphate-citrate lyase, which is involved in making cholesterol. This medication is administered as a 180-mg dose, and is approved by the USFDA and European Union for treating hypercholesterolemia. In the US, Bempedoic acid is indicated for treatment along with diet and the highest tolerated statin therapy in adults with heterozygous familial hypercholesterolemia, or with established ASCVD, who need additional lowering of LDL cholesterol.
Mumbai, May 18, 2022: Sun Pharmaceutical Industries Limited (Reuters: SUN.BO, Bloomb: SUNP IN, NSE: SUNPHARMA, BSE: 524715, “Sun Pharma” and includes its subsidiaries and/or associate companies) announced that one of its wholly owned subsidiaries plans to launch a first-in-class oral drug, Bempedoic Acid, in India for reducing low-density lipoprotein (LDL) cholesterol. The company will launch the drug under the brand name “Brillo®”.
Brillo® is a first-in-class drug which has a new mechanism of action compared to the currently available lipid-lowering agents. It is indicated for people who have an inherited genetic disorder that causes high cholesterol levels or established heart disease where cholesterol levels remain high, despite lifestyle changes and the use of maximum tolerated dose of statins.
Kirti Ganorkar, CEO- India Business, Sun Pharma said, “Sun Pharma is the leader in the cardiovascular segment and a pioneer in lipid-lowering therapy in India. In line with our commitment to introducing novel products, we are launching this first-in-class oral drug, Brillo®. It is a novel treatment option that will help manage high LDL cholesterol in patients with heart diseases, a condition which is growing at an alarming rate.”
One in four deaths in India is now because of heart diseases, with ischemic heart disease and stroke responsible for >80% of this burden. These diseases tend to affect patients in the most productive years of their lives and result in catastrophic social and economic consequences.
The burden of heart disease at 272 per 1,00,000 population in India is higher than the global average of 235 per 1,00,000 population. Some patients with elevated cholesterol levels may respond inadequately to statins. There also a set of patients who are intolerant to statins. Bempedoic acid can be a useful treatment option for such patients. The launch of Brillo® will address this significant unmet need in India.
Bempedoic acid is a novel class of non-statin therapy that targets hepatic cholesterol synthesis and has demonstrated significant LDL-C lowering ability as monotherapy and especially in combination with ezetimibe. If data on long-term safety and cardiovascular outcomes in ongoing trials are favorable, bempedoic acid will improve cardiovascular risk prevention in statin-intolerant patients and in resource limited settings.
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