US – Dr. Reddy’s Laboratories Ltd, a leading multinational pharmaceutical company based in India and overseas, has launched its U.S. Food and Drug Administration (USFDA) approved 1-gram Icosapent ethyl capsules.
The drug was approved as a diet supplementary to reduce triglyceride (TG) levels in adult patients with severe hypertriglyceridemia, a condition associated with high amounts of fatty molecules(triglyceride) in the blood and can result to a patient having skin lesions.
Icosapent ethyl capsule approval and launch was timely at a time when hypertriglyceridemia and its related complications are becoming a thing of concern in the US and the world at large, according to a U.S based study, over 12 million Americans are treated for high levels of TG annually.
According to Coherent Market Insights, the global hypertriglyceridemia therapeutics market was valued at US$ 9,716.6 million in 2020 and is projected to exhibit a CAGR of 4.09% during the forecast period (2020-2027) owing to the increased approval of novel drugs to treat the condition.
Dr. Reddy’s Icosapent ethyl capsule will join the already growing market of triglyceride-lowering therapies with notable existing drugs like Rosuvastatin Calcium Tablets launched by Mylan in the U.S, AstraZeneca’s Crestor Tablets, Sun Pharma’s Ezallor Sprinkle and Amarin Corporations’ VASCEPA.
With its launch, Dr. Reddy gave out important information about the drug usage which mostly highlighted the side effects of using it.
Using Icosapent Ethyl is associated with an increased risk of heart arrhythmias (atrial fibrillation or atrial flutter) requiring hospitalization and it is also associated with increased risk of bleeding.
The most common adverse reactions after usage include musculoskeletal pain, swelling of the hands, legs, or feet, constipation and Gout.
Additionally, a cautionary advise in reference to the drug was issued highlighting that the drug is not approved as an adjunct to maximally tolerated statin therapy to reduce the risk of myocardial infarction, stroke, coronary revascularization, and unstable angina requiring hospitalization in adult patients with elevated triglyceride (TG) levels and established cardiovascular disease or diabetes mellitus and two or more additional risk factors for cardiovascular disease.