The intention is to take a precision medicine approach to addressing the burden of cardiovascular disease, by focusing efforts on high-risk patients most vulnerable for future CV events, such as those who have suffered a previous event and are unable to reduce their LDL cholesterol (LDL-C) below 100 mg/dL despite statin therapy.
Praluent reduced the overall risk of MACE - which includes heart attack, ischemic stroke, death from coronary heart disease (CHD), or unstable angina requiring hospitalisation - by 15 percent, and was also linked with a lower death risk of death overall, the firms noted.
"I think that will impress the field and people who have to make (reimbursement) decisions", said Dr. Phillippe Steg, the study's co-chairman who presented the data at the American College of Cardiology meeting in Orlando, Florida. Based on the results of ODYSSEY Outcomes, ICER said it had calculated two new value-based price benchmarks for alirocumab in patients with a recent ACS event: $2,300-$3,400 per year if used to treat all patients who meet trial eligibility criteria, and $4,500-$8,000 per year if used to treat higher-risk patients with LDL-C of at least 100 mg/dL despite intensive statin therapy.
The study tested the injected biotech drug versus placebo in almost 19,000 patients who had a recent heart attack or severe chest pain episode and were already on maximum doses of cholesterol-lowering statins, such as Pfizer's Lipitor. In the USA, alirocumab is approved for use as an adjunct to diet and maximally-tolerated statin therapy for the treatment of adults with heterozygous familial hypercholesterolemia or clinical atherosclerotic cardiovascular disease who require additional lowering of LDL-C. "With almost 90 percent of the patients in this trial on high-intensity statins, the data demonstrate that a precision-medicine approach in the field of cardiovascular disease may further advance how we better treat high-risk patients". This results in an increased number of available LDL receptors on the surface of liver cells, which reduces the levels of LDL-C in the blood.More news: Apple Updates MFi Logo, Company Set To Change Packaging
The trial was created to maintain patients' LDL-C levels between 25-50 mg/dL, using two different doses of alirocumab (75 mg and 150 mg).
For those in the Praluent treatment arm, an estimated 75% of patient time was on the 75 mg dose.
High-risk patients who were subjected to Praluent injection in combination with maximally-tolerated statins had significantly lesser major adverse cardiovascular events compared to patients treated on only maximally-tolerated statins.
Regeneron president and chief scientific officer George Yancopoulos said: "This trial was consistent with earlier statin trials, showing the greatest benefit in patients with higher cholesterol levels at baseline".More news: French league will investigate fan violence in Lille
"Too many patients in urgent need of additional treatment options on top of statins have faced tremendous hurdles to gain access to this important medicine".
"With almost 90 percent of the patients in this trial on high-intensity statins, the data demonstrate that a precision-medicine approach in the field of cardiovascular disease may further advance how we better treat high-risk patients", added Elias Zerhouni, president, Global R&D, Sanofi.More news: India grounds 11 Indigo, GoAir jets after engine shutdowns