New Heart Failure Drug Possibly on the Horizon?

Novartis, a company that develops drugs and vaccines has just been granted an FDA priority review of a new heart failure drug called LCZ696. The company is well known worldwide for the manufacture of drugs such as clozapine, valsatan and methylphenidate. This new drug, LCZ696, has its final FDA action date in August of 2015 and has received accelerated assessment in the European Union. The drug will be dosed twice daily and will work by strengthening protective neurohormonal systems of the heart while also reduces harmful effects of the renin-angiotensin-aldosterone system. This new drug is predicted to reduce the risk of cardiovascular-related deaths by approximately 20%.

A study was conducted by Novartis and overseen by an executive committee, an independent data and safety committee. The trial consisted of three phases where informed patients who were 18 years of age, had New York Heart Association class II, III or IV symptoms, ejection fraction of less than 35% and required to have a plasma B-type natriuretic peptide level of at least 150 pg per milliliter. The first phase consisted of patients receiving enalapril (an ACE inhibitor), a single-blind run in which all patients then received LCZ696 and then a double-blind treatment in the two study groups. A total of 10,521 patients in 1043 centers in 47 countries were recorded with 4187 patients going into the actual trials. Death from cardiovascular causes or hospitalization for heart failure occurred in 914 (21.8% of patients in the LCZ696) & 1117 (26.% of patients in the enalapril) patients. LCZ696 reduced the risk of hospitalization from heart failure by 21% (P<0.001) and had higher proportions of patients with hypotension, nonserious angioedema but lower proportions with renal impairment, hyperkalemia and cough than the enalapril group.

I thought that this article was really interesting to know what kind of new drug could be appearing in hospitals in the future. It is great that this shows some improvement than the ACE inhibitor it was compared against in this very large, multi-continental study. I wonder what will happen with the FDA later this year and if this drug will be on the market in the United States in the near future. I also wonder what those implications will be for those with heart failure and the different side effects that nursing will manage if this drug does come onto the market.

Sources:

http://www.nejm.org/doi/full/10.1056/NEJMoa1409077#t=articleBackground

http://www.bidnessetc.com/34902-novartis-ag-adr-heart-failure-drug-granted-fda-priority-review/