INDIA – Sun Pharmaceutical Industries intends to launch Bempedoic Acid, a first-in-class lipid-lowering oral drug that aids in the reduction of low-density lipoprotein (LDL) cholesterol, in India under the brand name Brillo.
Brillo is a first-in-class drug with a novel mechanism of action when compared to other lipid-lowering agents currently on the market.
According to the company, 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 the 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.”
Some patients with high cholesterol levels may not respond well to statins, and some patients are intolerant to statins. Bempedoic acid may thus be an effective treatment option for such patients.
The launch of Brillo will address this significant unmet need in India.
High cholesterol raises a person’s risk of developing heart and circulatory diseases such as heart attack and stroke.
Heart diseases now account for one in every four deaths in India, with ischemic heart disease and stroke accounting for more than 80% of this burden.
The burden of heart disease in India is 272 per 100,000 people, which is higher than the global average of 235 per 100,000 people.
These diseases typically strike patients during their most productive years, resulting in disastrous social and economic consequences.
Meanwhile, following a customer complaint, Sun Pharma is recalling approximately 10,500 bottles of a generic drug intended for the treatment of major depressive disorders in the US market.
According to the most recent US Food and Drug Administration (USFDA) enforcement report, the domestic pharma major’s US arm is recalling 10,548 bottles of bupropion hydrochloride extended-release tablets from the American market.
The medication is used to treat depression as well as to prevent Seasonal Affective Disorder (SAD). It is also used to assist people in quitting smoking.
The affected lot of medication was produced at the drugmaker’s Halol (Gujarat) manufacturing plant. Sun Pharmaceutical Industries Inc. of New Jersey distributed the medication in the United States.
On April 29, this year, the company began the Class III nationwide (US) voluntary recall.
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