In early February, in response to the government’s outreach, Alexion reached out to the U.S. Department of Health and Human Services’ Biomedical Advanced Research and Development Authority (BARDA) office, the Department of Defense (DoD) and others within government to discuss the potential use of SOLIRIS® (eculizumab) in patients with COVID-19. We have let them know that while there are no clinical data supporting the role of terminal complement in coronaviral pneumonia, we believe that there is preclinical scientific rationale for its potential role in a subset of patients – those with coronaviral infection with severe pneumonia or acute respiratory distress syndrome (ARDS). Alexion is also in the process of discussing possible options to investigate SOLIRIS in COVID-19 with global health authorities in order to better understand the role of terminal complement inhibition in managing the severe pneumonia associated with the virus. While these discussions are underway, at the request of physicians, and in accordance with relevant national regulatory agencies, Alexion has provided SOLIRIS as an experimental emergency treatment for a small number of patients with COVID-19 infection and severe pneumonia. Requests are assessed on a case-by-case basis, with priority given to those with clinical trial experience and the oversight of a physician who has extensive experience using SOLIRIS. However, given that SOLIRIS is not approved for COVID-19 and there have not been any clinical trials to date, we cannot speculate on the outcome of our ongoing discussions, possible next steps or the potential role or efficacy of SOLIRIS in COVID-19.
Alexion is prepared to support the appropriate government agencies in their efforts to address this public health crisis. Above all, we remain committed to continuing to serve the patients who currently rely on our medicines and providing continuous supply to these patients.