Weigh! Novartis heart failure new drug lcz696 is approved for market in China

Novartis announced on July 28 that the heart failure drug entresto (sacubatrevalsartan sodium tablets, lcz696) was officially approved by CFDA for marketing to reduce the risk of cardiovascular death and hospitalization of heart failure in adults with reduced ejection fraction Entresto is considered to be the heaviest new drug in Novartis in recent years It was once regarded as the successor product of Glivec It is predicted that the annual sales peak can exceed 5 billion US dollars Entresto is so valued because of the huge clinical demand of the drug market for heart failure In the large-scale param-hf study with the largest number of patients with heart failure (n = 8442), entresto has been shown to significantly reduce the risk of cardiovascular death by 20%, the risk of hospitalization for heart failure by 21%, and the risk of all-cause death by 16% compared with enalapril The param-hf study was terminated ahead of schedule, and the FDA approved entresto for listing six weeks in advance Since the initial $4500 / year pricing was not accepted by payers, entresto's post IPO performance has been unsatisfactory, and only $21 million was received in 2015 However, on May 21, 2016, the updated guidelines of American College of Cardiology (ACC) / American Heart Association (AHA) / American Society of heart failure (HFSA) and European Society of Cardiology (ESC) all gave grade I recommendations for entresto in the treatment of heart failure (see: the wind is coming, entresto, a new drug of Novartis heart failure, has been strongly recommended by European and American clinical guidelines) As Novartis changed its pricing strategy, increased its marketing efforts, and expanded its sales force, entresto's sales gradually picked up In Novartis' latest quarterly report of 2017q2, entresto achieved a quarter on quarter sales revenue of $110 million, up 31% month on month (see: Novartis' 2017h1 performance: net revenue of $23.8 billion, and entresto, a heart failure drug, up 300%) The sales volume of lcz696 (US $100 million) entresto is a salt complex crystal formed by the combination of sakubaqu and Valsartan in the ratio of 1:1 mole It is the first drug of the type of angiotension receptor enkephalinase inhibitor (Arni) Compared with the existing heart failure drugs, it has obvious treatment advantages Entresto was approved by FDA on July 7, 2015, and EU on November 19, 2015 On March 14, 2016, entresto submitted its application for listing in China On December 2, 2016, entresto was included in the priority review by CDE for the reason of "obvious treatment advantage compared with existing treatment methods" Entresto's time to market in China is only two years later than that in the United States, and it has once again fulfilled the favorable policy of CDE priority review system for some new drugs with real clinical treatment advantages (see the drug review speed under "priority review" - the fastest approval only takes 17 days) Heart failure is mainly manifested as insufficiency of heart pump blood, which is a potentially fatal disease Most patients need lifelong treatment There are about 60 million heart failure patients in the world, including about 5.7 million in the United States Heart failure is the main cause of hospitalization for the elderly over 65 years old, with a global health expenditure burden of about US $108 billion per year A large-scale epidemiological survey in 2003 showed that the prevalence of heart failure among adults in mainland China has reached 0.9%, with 4.5 million heart failure patients.