Reduce-IT "substantially underway" status- any updates?
Ask Stephen Schultz by sending him an E mail or tel.call?
AKANZ is right--they are focussing on certain group of patients.
If you remember--JUPITER trials--by CRESTOR (ASTRA ZENECA)--very large group initially-but then results in different groups were looked at. One group showed remarkable results.So that data wassubmitted to FDA in 2009 (2 years into 5-6 years study).FDA panel voted with big majority for approval--and it was approved in 2010 by FDA for expanded labeling.
Sales were 4.5 bil.$ in 2009--shot up to 6.5 bil.$ in 2011.
OUTCOME trials --based on JELIS trials results--should PROVE that IT is an important Heart drug--not just a drug that lowers Trigyl.
Akanz- Glad to hear you don't qualify due to not being sick enough! =)
First patient was dosed last year in Reduce-It:
"BEDMINSTER, N.J., and DUBLIN, Ireland, Dec. 7, 2011 (GLOBE NEWSWIRE) -- Amarin Corporation plc (Nasdaq:AMRN), a late-stage biopharmaceutical company with a focus on cardiovascular disease, today announced the dosing of the first patient in REDUCE-IT, the cardiovascular outcomes study utilizing AMR101.
REDUCE-IT (Reduction of Cardiovascular Events with EPA - Intervention Trial), a multinational, prospective, randomized, double-blind, placebo-controlled, parallel-group study, will evaluate the effectiveness of AMR101 in reducing the prevalence of first major cardiovascular events in a high-risk patient population. All patients in the study will be receiving optimized statin therapy. The active arm of the study will involve patients on optimized statin therapy plus AMR101. All patients enrolled in the study will have elevated triglyceride levels and either coronary heart disease or risk factors for coronary heart disease. Planned enrollment for the trial is approximately 8,000 patients.
"Dosing of the first patient in this study is another significant milestone for Amarin," said Joseph Zakrzewski, Amarin's Chairman and CEO. "The results of REDUCE-IT may enable us to seek additional indications for AMR101 including cardiovascular prevention, which would target a patient population estimated to be almost twice that of the combined indications studied in the MARINE and ANCHOR trials or approximately 70 million adults in the U.S. alone."
Deepak L. Bhatt, M.D., M.P.H., Chief of Cardiology at the VA Boston Healthcare System, Director of the Integrated Interventional Cardiovascular Program at Brigham and Women's Hospital and VA Boston Healthcare System, and principal investigator of REDUCE-IT, said "AMR101 has an excellent safety profile and exceeded the expectations for the treatment of high and very high triglyceride levels in the Phase 3 MARINE and ANCHOR trials. Even beyond LDL-C control with statins, there remains a high unmet medical need for the reduction of cardiovascular risk in the patient population with high triglycerides. Importantly, with REDUCE-IT, we anticipate enrolling a significant number of patients with diabetes similar to the population in the ANCHOR trial."