Federal Judge allows Amarin to Promote Benefits not covered in FDA-approved Labeling of Vascepa

A twist in the tale came when a Federal judge in New York approved Amarin Pharma’s request for a ban against the enforcement by the US Food and Drug Administration of rules, which otherwise does not allow communicating physicians about the information on unapproved uses of its Vascepa.

As per the order, the company can share the information about the drug’s effect witnessed in the late-stage ANCHOR trial. In the trial, the product was tested on patients having quit high levels of triglycerides after statin therapy.

The company can also promote the product through peer-review journals. Amarin was of the view that the use of the drug studied in the trial is medically accepted and physicians also prescribe it. Even though the FDA has not approved Vascepa for this, it is a practical reality.

In 2013, the FDA cancelled a special protocol assessment (SPA) for the ANCHOR trial with regard to Amarin’s request to expand the drug’s use among adults having high triglycerides with mixed dyslipidaemia. In fact, it also gave a hint that it has no plans to restore the SPA.

CEO John Thero said that the lawsuit is based on a fact that if doctors will be better informed about the drug then they will be in a better position to take decision for their patients. There are many physicians who are aware of the data included in

FD-approved labeling for Vascepa, but not about from the ANCHOR study. The ruling will remain in effect until next hearing takes place.