Novartis announced that the Committee for Medicinal Products for Human Use (CHMP) has adopted a negative opinion for the use of RLX030 (serelaxin) in the treatment of acute heart failure (AHF) indicating that further evidence is required for a license to be granted in the EU. This follows the company’s request for re-examination after a previous negative opinion was issued in January. Novartis aims to resubmit for approval as soon as additional data is available from the ongoing global trial programme, including the 6,300 patient RELAX-AHF-2 study, one of the largest and most robust programmes undertaken by a company for an AHF drug.
“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,” said Tim Wright, Global Head of Development, Novartis Pharmaceuticals. “20 million people across the world face poor quality of life and high risk of death from heart failure and it remains our mission to change the course of this disease with our research and development efforts.”
Heart failure is a debilitating and potentially life-threatening condition where the heart cannot pump enough blood around the body. This, in most cases, happens because the heart muscle responsible for the pumping action weakens over time or becomes too stiff. Heart failure is a significant and growing public health concern affecting over 20 million people worldwide and costing the world economy $45 billion annually.