Jan 15 Amarin Corp Plc said U.S. health
regulators delayed their decision to reconsider a rescinded
agreement that could support a marketing application for an
expanded use of the company's blood fat-lowering drug.
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. Following an appeal from
Amarin, the regulator said it would determine by Jan. 15 whether
it would reconsider that decision.
Shares of the Irish drugmaker, which closed up 15 percent on
the Nasdaq on Wednesday in anticipation of a decision, fell 6
percent in trading after the bell.
Amarin said on Wednesday that the FDA in its communication
provided no definitive date for its planned response, but that
the company does not expect the delay to be significant based on
its dialogue with the agency.
The SPA was revoked after an advisory panel to the FDA had
recommended against its approval for use in a broader patient
population until results from the larger trial had been
The regulator determined then that a substantial scientific
issue essential to determining the effectiveness of Vascepa in
the expanded population was identified only after the trial
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.