Jan 21 Amarin Corp Plc's shares fell
more than 25 percent in premarket trading after U.S. health
regulators rejected a preset testing process as the company
seeks broader use of its blood fat-lowering drug.
The Irish drugmaker said it planned to appeal the decision,
but that it does not expect a decision on the extended use of
the drug while the appeal is pending.
The U.S. Food and Drug Administration had in October revoked
a Special Protocol Assessment (SPA) agreement covering a large
late-stage trial of the drug, Vascepa.
Such deals provide companies assurance that the design and
analysis of a trial are adequate to support a marketing
application submission with the U.S. health regulator.
Following an appeal from Amarin, the regulator said it would
determine by Jan. 15 whether it would reconsider that decision.
The SPA was revoked after an advisory panel to the FDA had
recommended against the drug's approval for use in a broader
patient population until results from the larger trial had been
The regulator had then said a substantial scientific issue
essential to determining the effectiveness of Vascepa in the
expanded population was identified only after the trial began.
Vascepa was approved in 2012 to reduce high levels of
triglycerides - a type of blood fat that can increase the risk
of heart disease - in patients not taking cholesterol-lowering
statins such as Pfizer Inc's Lipitor.
In a bid to broaden the drug's market and improve sales,
Amarin applied last February for approval to sell Vascepa to
patients with blood fat abnormalities who are at high risk of
coronary heart disease and are also taking statins.
(Reporting by Natalie Grover in Bangalore; Editing by Saumyadeb