Flush with a promising set of late-stage data for the triglyceride-reducing AMR101, Amarin ($AMRN) plans to take a quick shortcut to the FDA, seeking an approval a full year ahead of schedule. The developer also announced this morning that the prescription-strength omega-3 fatty acid therapy did not raise levels of "bad" LDL cholesterol, and its shares soared 51 percent on the news.
Investigators recruited patients with dangerously high triglyceride levels--blood fat linked to heart disease--rising above a mark of 500 milligrams-per-deciliter. Patients either received two doses of AMR101 or a placebo over 12 weeks. Patients in a high-dose group demonstrated a 33 percent reduction in triglyceride compared with placebo, while a low-dose group experienced a 20 percent drop. And one subset with particularly high triglyceride levels demonstrated a 45 percent plunge after taking a high dose, equivalent to the number recorded for GlaxoSmithKline's Lovaza.
"We believe that these results and the overall profile of AMR101 position the drug candidate to be best in class in this market," Amarin CEO Joseph Zakrewski told Bloomberg. In a statement, the biotech company called AMR101 "the first and only triglyceride-lowering therapy studied in this population with very high triglyceride levels to show a lack of elevation in LDL-C." A second late-stage study of the drug is expected to finish recruiting patients by the end of this month.
- get the press release
- here's the Bloomberg story
- check out the Dow Jones report
- read the story from TheStreet