Novartis To Continue Investigation Of Serelaxin In AHF
Novartis reported that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has confirmed its initial negative opinion of RLX030 (serelaxin) as a treatment for acute heart failure (AHF). The CHMF’s confirmation follows Novartis’ request for re-examination of its application after the committee issued a previous negative opinion of the drug back in January.
Following this recent negative opinion, CHMF stated that further evidence was needed before serelaxin can be licensed in the EU. RLX030 is a form of the naturally occurring hormone known as human relaxin 2, which, while both men and women have the hormone, particularly becomes elevated in women during pregnancy. The hormone helps the body cope with the additional cardiovascular demands of pregnancy. Serelaxin relaxes the blood vessels and reduces fluid buildup. The company added that certain evidence suggests that serelaxin can reduce heart and vital organ damage, an important effect when considering the damage that occurs during an acute heart failure episode.
Heart failure is a disabling and life-threatening condition in which the heart fails to pump enough blood around the body. This is mainly due to weakness or stiffness of the heart muscle responsible for pumping action. AHF affects more than 20 million people around the world and is estimated to cost the world economy $45 billion every year.
"We are disappointed that patients in Europe will not have access to RLX030 in 2014 but we believe in the value that RLX030 can bring to patients and are committed to extending the current evidence base to confirm this.” Wright said that Novartis will continue research into potential treatments for AHF.
Global trials are underway for serelaxin, including the 6,300 patient RELAX-AHF-2 study, currently one of the largest programs conducted by a pharmaceutical company for an investigational drug in acute heart failure. The company said it plans to resubmit an application for approval once data from the studies become available.