Hikma Gets US FDA Approval For Generic Version Of Heart Drug Vascepa

(Alliance News) - Hikma Pharmaceuticals PLC on Thursday said the US Food & Drug Administration ...

Alliance News 22 May, 2020 | 9:29AM
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(Alliance News) - Hikma Pharmaceuticals PLC on Thursday said the US Food & Drug Administration has approved its Icosapent Ethyl capsule.

The pharmaceuticals company said its wholly-owned US subsidiary Hikma Pharmaceuticals USA Inc has secured regulatory approval for a generic version of Vascepa, a drug designed to reduce the risk of heart attack, stroke and certain types of heart issues.

Hikama noted that the decision by the US District Court for Nevada to invalidate six key Vascepa patents owned by Amarin Corp is being appealed. Amarin had sued Hikma for infringement on five patents it held for Vascepa. However, the US court ruled the patent claims were invalid.

"The approval for our generic version of Vascepa is an important milestone towards bringing this product to market. This approval demonstrates the strength of our regulatory capabilities and our commitment to provide patients and healthcare providers in the US with the high-quality medicines they need," said Brian Hoffmann, president of Generics at Hikma.

The FTSE 100 stock was trading 1.5% higher at 2,553.00 pence each on Friday morning in London.

By Ife Taiwo; ifetaiwo@alliancenews.com

Copyright 2020 Alliance News Limited. All Rights Reserved.

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Securities Mentioned in Article

Security Name Price Change (%) Morningstar
Rating
Hikma Pharmaceuticals PLC 2,120.00 GBX 0.71

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