KEYPOINTS:
- The product is a generic version of the Lupin Atlantis Holdings, S A Corporation’s Antara capsules
- Fenofibrate Capsules (RLD: Antara Capsules) had estimated annual sales of USD 7 million in the U.S.
- Fenofibrate Capsules are indicated as adjunctive therapy to diet to reduce elevated low-density lipoprotein cholesterol, total cholesterol, triglycerides, and apolipoprotein B, and to increase high-density lipoprotein cholesterol in adult patients with primary hypercholesterolemia.
Lupin Launches Authorized Generic Version of Antara (Fenofibrate) Capsules in the United States.
Global pharma major Lupin Limited announced the launch of the authorized generic version of Antara (Fenofibrate) capsules, 30 mg and 90 mg, of Lupin Atlantis Holdings, S.A. Corporation, a wholly-owned subsidiary of Lupin.
Fenofibrate capsules are indicated as adjunctive therapy to diet to reduce elevated low-density lipoprotein cholesterol (LDL-C), total cholesterol (total-c), Triglycerides (TG) and apolopoprotein B (Apo B), and to increase high-density lipoprotein cholesterol (HDL-C) in adult patients with primary hypercholesterolemia.
Fenofibrate Capsules had estimated annual sales of US$7 million in the US, according to IQVIA MAT September 2021.
According to IQVIA MAT September 2021 data, Fenofibrate capsules had estimated annual sales of $7 million in the US, Lupin said
What is Fenofibrate?
Fenofibrate is an oral medication of the fibrate class used to treat abnormal blood lipid levels. It is less preferred to statin medications as it does not appear to reduce the risk of heart disease or death. Its use is recommended together with dietary changes.
Structure of Fenofibrate.
Molecular Formula C20H21ClO4
Molecular Weight 360.8
IUPAC Name propan-2-yl 2-[4-(4-chlorobenzoyl)phenoxy]-2-methylpropanoate
CAS RN 49562-28-9
Mechanism of Action (MOA):
Fenofibrate is a synthetic phenoxy-isobutyric acid derivate and prodrug with antihyperlipidemic activity. Fenofibrate is hydrolyzed in vivo to its active metabolite fenofibric acid that binds to and activates peroxisome proliferator activated receptor alpha (PPARalpha), resulting in the activation of lipoprotein lipase and reduction of the production of apoprotein C-III, an inhibitor of lipoprotein lipase activity. Increased lipolysis and a fall in plasma triglycerides, in turn, leads to the modification of the small, dense low density lipoporotein (LDL) particles into larger particles that are catabolized more rapidly due to a greater affinity for cholesterol receptors. In addition, activation of PPARalpha also increases the synthesis of apoproteins A-I, A-II, and high density lipoprotein (HDL)-cholesterol. Overall, fenofibrate reduces total cholesterol, LDL cholesterol, apolipoprotein B, total triglycerides and triglyceride rich lipoprotein (VLDL) while increasing HDL cholesterol.
Medical uses
Fenofibrate is mainly used for primary hypercholesterolemia or mixed dyslipidemia. Fenofibrate reduces risk and progression of diabetic retinopathy in type 2 diabetic patients. It was initially indicated for diabetic retinopathy in patients with type 2 diabetes and diabetic retinopathy in Australia. The large scale, international FIELD and ACCORD-Eye trials found that fenofibrate therapy reduced required laser treatment for diabetic retinopathy by 31%, as well as reducing progression by 3.7% over 4 years. Although no statistically significant cardiovascular risk benefits were identified in these trials, benefits may accrue to add on therapy to patients with high triglyceride dyslipidaemia currently taking statin medications.
Fenofibrate appears to reduce the risk of below ankle amputations in patients with Type 2 diabetes without microvascular disease. The FIELD study reported that fenofibrate at doses of 200mg daily, reduced the risk for any amputation by 37% independent of glycaemic control, presence or absence of dyslipidaemia and its lipid-lowering mechanism of action. However, the cohort of participants who underwent amputations were more likely to have had previous cardiovascular disease (e.g. angina, myocardial infarction), longer duration of diabetes and had baseline neuropathy.
Fenofibrate has an off-label use as an added therapy of high blood uric acid levels in people who have gout.
It is used in addition to diet to reduce elevated low-density lipoprotein cholesterol (LDL), total cholesterol, triglycerides (TG), and apolipoprotein B (apo B), and to increase high-density lipoprotein cholesterol (HDL) in adults with primary hypercholesterolemia or mixed dyslipidemia.
Severe hypertriglyceridemia type IV or V
It is used in tandem with diet for treatment of adults with severe hypertriglyceridemia. Improving glycemic control in diabetics showing fasting chylomicronemia usually reduces the need for pharmacologic intervention.
Statins remain the first line for treatment of blood cholesterol. AHA guidelines from 2013 did not find evidence for routine use of additional medications.
Additionally, in 2016, the FDA filed “Withdrawal of Approval of Indications Related to the Coadministration With Statins in Applications for Niacin Extended-Release Tablets and Fenofibric Acid Delayed Release Capsules” noting “the Agency has concluded that the totality of the scientific evidence no longer supports the conclusion that a drug-induced reduction in triglyceride levels and/or increase in HDL cholesterol levels in statin-treated patients results in a reduction in the risk of cardiovascular events. Consistent with this conclusion, FDA has determined that the benefits of niacin ER tablets and fenofibric acid DR capsules for coadministration with statins no longer outweigh the risks, and the approvals for this indication should be withdrawn.”
COVID-19
In August 2021, researchers in the UK and Italy reported laboratory findings that fenofibrate can significantly reduce SARS-CoV-2 infection in vitro
About Lupin:
Lupin is an innovation-led transnational pharmaceutical company headquartered in Mumbai, India. The Company develops and commercializes a wide range of branded and generic formulations, biotechnology products and APIs in over 100 markets in the U.S., India, South Africa and across Asia Pacific (APAC), Latin America (LATAM), Europe and Middle-East regions.
The Company enjoys a leadership position in the cardiovascular, anti-diabetic, and respiratory segments and has a significant presence in the anti-infective, gastro-intestinal (GI), central nervous system (CNS) and women’s health areas. Lupin is the third-largest pharmaceutical company in the U.S. by prescriptions. The company invested 9.6% of its revenue on research and development in FY21.
Lupin has 15 manufacturing sites, 7 research centers, more than 20,000 professionals working globally, and has been consistently recognized as a ‘Great Place to Work’ in the Biotechnology & Pharmaceuticals sector.
SOURCE: AUTHENTIC
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