Dublin-based Amarin ($AMRN) says the FDA has accepted the company's NDA for AMR101, a prescription omega-3 drug for the treatment of high triglycerides. Triglycerides are fats in the blood that can cause heart disease. The FDA is expected to rule on Amarin's drug by July 26.
Amarin's NDA is based on two Phase III trials of AMR101, which showed that patients who took the 4g and 2g-per-day doses of the drug saw triglyceride levels drop 21.5% and 10.1% respectively. Additionally, AMR101 didn't raise bad cholesterol levels in trial subjects. If approved, AMR101 will compete with GlaxoSmithKline's ($GSK) Lovanza, with sales of Amarin's drug predicted to top $3 billion by 2021, according to a Leerink Swann projection.
"We are very pleased with the FDA's acceptance for filing of our AMR101 NDA submission as it is a significant achievement in the development of what we believe is a next generation Omega-3 based triglyceride lowering therapy," said Amarin CEO Joseph Zakrzewski in a statement.
Though the company's drug is on track for a 2012 launch, Amarin still has to wrestle with concerns about the intellectual property surrounding its fish oil drug. Patent officials have twice issued rejection notices for a filing on AMR101, causing analysts to worry that Amarin will have a shortened period of exclusivity for its drug.
- check out Amarin's release
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