The decision came after meeting with the FDA’sCenter for Devices and Radiological Health and Center for Drug Evaluation and Research in which the company came to the conclusion that “there would be no significant time or cost advantage associated with pursuing the EAP designation for CytoSorb for the treatment of sepsis.”
CytoSorbents said based on that data, it decided to scrap plans to pursue the EAP and instead pursue an investigative device exemption and premarket approval for the device.
“Based upon the criteria of the EAP program, we believed that it was possible to obtain EAP designation for CytoSorb and pursue a registration trial using surrogate endpoints, rather than 28-day all-cause mortality – an endpoint that no sepsis treatment has been able to achieve in pivotal trials – for early market approval. We are obviously disappointed that this was not the case,” CEO Dr. Phillip Chan said in a press release.
The Monmouth Junction, N.J.-based company said the IDE and PMA route eliminated the potential that it would require a post-market efficacy study, which could have been required through an EAP route.
“However, based upon our positive clinical experience and the significant international research being conducted on CytoSorb today, we continue to believe that CytoSorb blood purification is one of the most promising treatments for sepsis. Unlike previous treatment attempts by other companies, CytoSorb attacks sepsis from many different angles, such as a reduction of excessive pro-inflammatory cytokines and inflammatory mediators, a reduction in many pathogenic toxins, a stabilization of various key organ parameters such as hemodynamics, and a re-direction of the immune response to prevent cell-mediated injury of vital organs. We strongly believe the effectiveness of this broad approach is one of the reasons CytoSorb adoption and usage in sepsis continues to grow,” Chan said in prepared remarks.
CytoSorbents said the FDA offered to aid the company with its sepsis clinical trial design once it has submitted a formal IDE.
“CytoSorb has been credited with successfully saving the lives of many patients all over the world. We remain committed to moving forward with our U.S. clinical program in sepsis under the traditional IDE pathway and appreciate the FDA’s offer to review our future plans. In doing so, we hope to stem the tide of one of the top ten causes of death in the United States for which no approved therapy currently exists,” Chan said in a prepared statement.
CytoSorb won CE Mark approval in the European Union in 2011. The device is designed to filter inflammation-causing substances such as cytokines from the blood, the company said.