FDA Approves Generic Equivalent to Vascepa

The US Food and Drug Administration (FDA) has granted approval of a generic equivalent to icosapent ethyl (Vascepa) to London-based Hikma Pharmaceuticals Inc., the company announced in a statement.

The approval of Icosapent Ethyl Capsules, 1 gm, comes less than 3 months after a United States District Court for the District of Nevada invalidated 6 Vascepa patents owned by Amarin, which is currently being appealed, and less than 6 months after the FDA’s initial approval of icosapent ethyl (Vascepa).

At the time of the approval, the Amarin therapy became the first indicated by the FDA for cardiovascular risk reduction among patients with elevated triglyceride levels as an add-on to maximally tolerated statin therapy.

"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 Hikma Pharmaceuticals’ Generics business unit, in the aforementioned statement.

This is an ongoing story and will be updated when more information becomes available.