Kill move of Sanofi PCSK9 McAb: 15% reduction of death risk, 70% reduction of price

Source: Medical magic cube data March 10, 2018, regeneron / Sanofi announced that the large-scale Odyssey outlets study of PCSK9 monoclonal antibody, praluent (alirocumab) reached the main end point Detailed results were presented at the 67th Annual Meeting of the American College of Cardiology The Odyssey outcoms study included 18924 patients who had acute coronary syndrome within 12 months before admission, who received the maximum tolerable dose of statins combined with praluent (75150mg) or placebo, with an average follow-up of 33 months The results showed that praluent reduced the risk of major cardiovascular events (Mace, including heart attack, ischemic attack, coronary death, unstable angina requiring hospitalization) by 15%, and the risk of all-cause death by 15% For patients with baseline LDL-C level ≥ 100mg / dl, the long-term benefits of praluent were more significant, reducing the risk of major cardiovascular events by 24% (11.5% vs 14.9%), and the risk of all-cause death by 29% (4.1% vs 5.7%) Sanofi / apluent became the first PCSK9 McAb to prove that it can reduce the risk of all-cause death At the same time, Sanofi announced a significant reduction in the price of praluent, from the initial $14000 / year retail price to $4460-7975 / year, equivalent to a minimum of $12 per day On December 1 last year, an additional application for repatha (evolocumab) of PCSK9 monoclonal antibody was approved by FDA to reduce the risk of heart attack (myocardial infarction), stroke and coronary artery reconstruction in adult patients with cardiovascular disease In a large cardiovascular outcome study, code named Fourier, involving 27564 patients, repatha combined with the optimal dose of statins reduced the risk of the primary composite end point (cardiovascular death, myocardial infarction, stroke, hospitalization for unstable angina or coronary revascularization) by 15%, and the key secondary composite end point (primary cardiovascular event, including first heart attack, stroke) , cardiovascular death) Repatha reduced the risk of heart attack by 27%, stroke by 21%, and coronary artery reconstruction by 22% In addition, both primary and secondary endpoints, repatha showed clinical benefits at the 6th month of follow-up, and with the extension of follow-up time (to the median follow-up period of 2.2 years), the clinical benefits were significant However, repatha failed to demonstrate the benefit of death risk in Fourier study PCSK9 is highly competitive Currently, Amgen repatha has about 60% market share (USD 319 million), and Sanofi praluent has about 40% market share (USD 194 million) In addition to the clinical benefits and price competition, Amgen once sued Sanofi / zayuan for infringement in an attempt to prevent praluent from selling in the US market After statins, with the complete withdrawal of CETP, the competition around PCSK9 became intense Etc1002, a small molecule lipid-lowering drug developed by esperion, also directly attacked the high price weakness of PCSK9 After the announcement, the price will definitely be less than 4000 US dollars per year The RNAi lipid-lowering drug developed by the medicine company targeting PCSK9 is also in phase III, which is full of imagination.