New cholesterol drug lowers heart attack, death risk in study

New cholesterol drug lowers heart attack, death risk in study

Alongside the data the companies announced plans to boost the affordability and accessibility of Praluent for patients most in need, by offering a reduced net price to United States payers that agree to reduce "burdensome access barriers" for high-risk patients. The new price will be in alignment with a value assessment for this population from the Institute for Clinical and Economic Review (ICER).

The offer has been made just after the presentation of the large-scale ODYSSEY OUTCOMES at the American College of Cardiology (ACC) meeting in Orlando, which showed that adding PCSK9 inhibitor Praluent (alirocumab) to high-dose statins reduced cardiovascular events and all-cause mortality compared to statins alone. Management sees population of 300K - 400K high-risk patients in US, only 38K being treated at present.

Now, Sanofi and Regeneron have laid down the gauntlet to their rival, saying they will "offer U.S. payers that agree to reduce burdensome access barriers for high-risk patients a further reduced net price for Praluent ... in alignment with a new value assessment for high-risk patients".

Praluent, or alirocumab, a relatively new cholesterol drug, is effective at lowering heart attack and death risk, according to a study sponsored by manufactuers Sanofi and Regeneron Pharmaceuticals. "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".

Praluent functions by preventing the binding of proprotein convertase subtilisin/kexin type 9 (PCSK9) to the LDL receptor.

Good news for people with very high cholesterol. 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.

The trial was created to maintain patients' LDL-C levels between 25-50 mg/dL, using two different doses of Praluent (75 mg and 150 mg).

Patients starting the trial with LDL cholesterol levels above 100 mg/dL saw improvements in all outcomes that were assessed, including rates of heart attack, stroke, unstable angina requiring hospitalization, coronary heart disease death, cardiovascular death and death from any cause.

In terms of safety and tolerability, the only significant difference between the two study groups was minor local site reactions (mild itching, redness or swelling) at the injection site, which occurred in 3.1 percent of those receiving alirocumab and 2.1 percent of those receiving placebo.

Representatives from the two companies will meet with health plans to examine prospective net pricing adjustments for those that agree to provide straightforward access to high-risk patients. "Through this trial, we have been able to identify high-risk patients treated with optimal statins who still have an urgent need for additional treatment options".

The companies followed the data with an announcement to cut the price of Praluent (alirocumab) for the high-risk patients who need it the most - a one-two combination aimed at knocking down Amgen and its rival, Repatha (evolocumab).

Related Articles