With COVID-19 cases rising at alarming rates across the US, Emergency Use Authorization of Regeneron’s COVID treatment couldn’t have come soon enough. The FDA announced late last month that casirivimab and imdevimab, two monoclonal antibodies, were authorized for emergency use in patients with mild and moderate Coronavirus Disease 2019.
Clinical trials demonstrated that the two drugs, when administered together, significantly reduced viral loads as well as COVID-19-related hospitalization and ER visits in patients at high risk for disease progression.
Bill Martin, Ph.D. of Evolution Research Group (ERG), which operates clinical research centers and provides drug development services, noted, “Our team is grateful to have participated in such an incredibly important program. We thank the many volunteers at our research centers that have contributed to the development of this important new treatment.”
ERG’s Chief Medical Officer stated “We are thrilled at the FDA’s recent decision to allow emergency use, which will have a tremendous impact on patients, their families as well has health care workers in the midst of the pandemic. These outcomes are a result of groundbreaking research and tremendous efforts by countless researchers.”
Casirivimab and imdevimab were designed to work by specifically bocking infectivity of SARS-CoV-2, the virus that causes COVID-19. The two drugs are administered together via infusion and drugs are not meant for those with severe symptoms or those who are hospitalized.
FDA officials also stated that emergency use may alleviate the burden on the healthcare system and keep patients out of the hospital.
ERG and its clinical research sites are dedicated to advancing medicine and continue to work with biopharmaceutical companies in the development of new treatments and vaccines for COVID-19.
To learn more about Regeneron’s emergency use authorization, visit regeneron.com.
