Amarin ($AMRN) shares soar on promising Ph3 triglyceride study
Flush with a promising set of late-stage data for the triglyceride-reducing AMR101, Amarin plans to take a quick shortcut to the FDA.
Flush with a promising set of late-stage data for the triglyceride-reducing AMR101, Amarin ($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 t
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