Release date: 2014-12-03 Novartis's high-risk heart-fighting drug LCZ696 has received great news in EU regulation. The European Medicines Agency (EMA) Human Pharmaceutical Products Committee (CHMP) has awarded LCZ696 accelerated assessment and became the first in the history of EU drug regulation. Obtained cardiovascular drugs eligible for accelerated assessment. Prior to this, the EU's accelerated assessment qualifications were never awarded to the cardiovascular sector. LCZ696 is an experimental drug developed for the treatment of patients with heart failure (HFrEF) with reduced ejection fraction. CHMP grants accelerated assessment, which means that the official review time of LCZ696 in the EU will be shortened by 60 days. Novartis is expected to submit LCZ696's listing permit application (MAA) in the EU in early 2015. The MAA submission will be based on the milestone of the Phase III PARADIGM-HF study, which is the largest scale in the heart failure patient population. The largest study, data show that LCZ696 efficacy and safety exceeds the clinical standard drug enalapril, including significantly lowering the risk of cardiovascular death or hospitalization for heart failure. In the European Union, there are approximately 15 million heart failure patients who, despite the availability of drugs, are at high risk of death and poor quality of life. In the United States, the FDA has granted the LCZ696 fast lane status, and Novartis expects to complete the rolling submission of the LCZ696 new drug application by the end of 2014. LCZ696 is a dual-effect angiotensin receptor enkephalinase inhibitor with a unique mode of action that is thought to reduce strain in failing hearts. LCZ696 combines Novartis's hypertension drug (Diovan, generic name: valsartan) and the experimental drug AHU-377. AHU377 blocks the mechanism of action of two peptides that are responsible for lowering blood pressure, while Diovan improves vasodilation and stimulates the body to excrete sodium and water. The safety threshold for cardiovascular drugs is extremely high, and LCZ696 even shows a higher safety than conventional drugs. Previously, the cardiovascular drug serelaxin developed by Novartis was rejected by the FDA and the EU because of safety issues, which was undoubtedly a heavy blow to Novartis. The success of LCZ696 will be repaid to Novartis in a major era in the cardiovascular field. The industry believes that the outstanding performance of LCZ696 makes this drug one of the most important advances in the field of cardiology in the past 10 years; at the same time, in the next few years, there will be no drugs in the cardiovascular field that can compete with LCZ696. Some analysts predict that LCZ696 sales peaked at $8 billion, and Deutsche Bank analysts expect the drug's peak sales to reach $6 billion, given LCX696's superior performance in reducing cardiovascular risk. Although the data of the parties are slightly different, there is no doubt that the LCZ696 will become a super-heavy star, which will bring the financial resources to Novartis, and will lead the cardiovascular treatment into a new era. Source: Bio Valley Swabs are ideal for collecting large numbers of samples and quickly eluting samples. It immediately releases specimens into transport media and is widely used in molecular genetics, forensic science, clinical laboratories, and more. Sponge Swab,Medical disposable sample collection sample flocking swab,A tube flocking swab for the collection of nasal cell samples,Single use Jiangsu iiLO Biotechnology Co., Ltd. , https://www.iilogene.com