Strides Pharma receives FDA approval for Icosapent Ethyl Capsules

Strides Pharma Science Limited (Strides) has achieved a significant milestone by announcing the United States Food & Drug Administration (USFDA) approval of Icosapent Ethyl Capsules 0.5 gram and 1 gram. This approval comes through its wholly owned subsidiary, Strides Pharma Global Pte. Limited, Singapore. The newly approved product seamlessly integrates into Strides’ portfolio of authorized soft gelatin capsules, enhancing its offerings in the pharmaceutical market.

A Therapeutic Breakthrough with Ample Market Potential

Icosapent Ethyl Capsules, now endorsed by USFDA, are not only bioequivalent but also therapeutically equivalent to the Reference Listed Drug (RLD), Vascepa, by Amarin. The significance of this achievement amplifies as the product taps into a market with a substantial size of approximately USD 1.3 billion, according to IQVIA. Strides Pharma Science Limited is primed to produce this groundbreaking product at its state-of-the-art facility located in Bengaluru.

A Trailblazing Pharmaceutical Player

With a commendable track record, Strides Pharma Science Limited boasts 260 cumulative ANDA filings, a number that includes the recently acquired portfolio from Endo at Chestnut Ridge, all meticulously reviewed by the USFDA. Impressively, over 230 of these ANDAs have already secured the coveted approval. As part of its strategic growth trajectory, the company has set a formidable target to introduce around 60 new products within the United States over the next three years.

Unraveling the Potential of Icosapent Ethyl Capsules

Strides’s Icosapent Ethyl Capsules come with a specific approval for the treatment of severe hypertriglyceridemia (TG levels ≥500 mg/dL) in adult patients, serving as an adjunct to their diet regimen. It’s a pharmaceutical advancement poised to make a meaningful impact on patient care and well-being.

Looking Forward to a Promising Future

While Strides’s Icosapent Ethyl Capsules address a significant health concern, it’s important to note that they are not approved for another indication, which is as an adjunct to maximally tolerated statin therapy for reducing the risk of myocardial infarction, stroke, coronary revascularization, and unstable angina requiring hospitalization in adult patients with elevated triglyceride (TG) levels (≥150 mg/dL) and established cardiovascular disease or diabetes mellitus, along with two or more additional risk factors for cardiovascular disease.

Strides Pharma Science Limited continues to forge ahead, making remarkable strides in the pharmaceutical industry, with a commitment to enhancing healthcare solutions for patients worldwide.