Amarin jumps on FDA priority review for heart drug
Irish company’s Vascepa on track for earlier than expected approval
The FDA grants priority review only to drugs that have the potential to offer significant improvement in the treatment of serious conditions.
The priority review means that Vascepa could receive approval as early as September, four months earlier than the company had previously projected.
If approved, Vascepa would be the first drug to manage cardiovascular risk in patients already taking statins to tackle high cholesterol, who also have high levels of blood fats called triglycerides. The company says it is a condition affecting millions of patients.
The FDA grants priority review only to drugs that have the potential, if approved, to offer significant improvement in the treatment of serious conditions compared with existing therapy options.
“We expect earlier approval of an expanded indication for Vascepa to lead to faster improvements in care for millions of patients with residual cardiovascular risk after statin therapy,” said Amarin chief executive John Thero.
Amarin is currently approved only from a much smaller niche indication – the lowering of triglycerides in patients who have extremely high levels of the blood fats.