Drugs Xagena
The FDA ( Food and Drug Administration ) Cardiovascular and Renal Drugs Advisory Committee ( CRDAC ) voted against approval for Serelaxin ( Reasanz ) for the treatment of acute heart failure ( AHF ).
Data presented at Advisory Committee meeting included phase II and III efficacy and safety data from the Serelaxin clinical development program, including the pivotal phase III RELAX-AHF study.
In this study Serelaxin has improved the symptoms of acute heart failure ( AHF ) through reducing the rate of worsening heart failure, a measure of symptom deterioration that requires intensification of therapy.
Relaxin is under review to improve the symptoms of acute heart failure through reduction of the rate of worsening of heart failure. Its proposed administration is in addition to conventional therapies, as a 48-hour infusion in the hospital during an AHF episode.
Serelexin, a relaxin receptor agonist, is a recombinant form of a naturally occurring hormone ( human relaxin 2 ) present in both men and women which rises in women during pregnancy to help the body cope with the additional cardiovascular demands.
Serelaxin has multiple effects including relaxing the blood vessels and reducing fluid buildup. Some evidence also suggests it can reduce damage to heart and vital organs, which may be of particular importance when considering the cascade of damage that occurs during an acute heart failure episode.
Serelaxin was granted Breakthrough Therapy ( BT ) designation status by the FDA in June 2013 for the ongoing development program.
The BT designation is independent of the BLA currently under review and its corresponding FDA action date.
The ongoing development program includes RELAX-AHF-2, a global, phase III outcomes study of more than 6,300 patients, of which approximately 1,000 will be from the US. The study began recruiting in 2013; results are expected in 2016 and will add to the current body of evidence for Serelaxin. ( Xagena )
Source: Novartis, 2014
XagenaMedicine_2014
