FDA grants Emergency Use Authorization for Regeneron’s antibody treatment
pharmafile | November 23, 2020 | News story | Sales and Marketing |
The FDA has granted Emergency Use Authorization for Regeneron’s coronavirus antibody treatment which was used to treat President Donald Trump when he was infected with COVID-19.
The treatment combines two antibodies, casirivimab and imdevimab, and administers them through an IV. In a clinical trial that involved 800 people, the combination therapy was shown to significantly reduce SARS-CoV-2 virus levels within days.
However, it is not authorised for patients who are hospitalised due to COVID-19 or require oxygen therapy due to the disease. FDA Commissioner Stephen M. Hahn said: “The FDA remains committed to advancing the nation’s public health during this unprecedented pandemic. Authorising these monoclonal antibody therapies may help outpatients avoid hospitalisation and alleviate the burden on our health care system.
“As part of our Coronavirus Treatment Acceleration Program, the FDA uses every possible pathway to make new treatments available to patients as quickly as possible while continuing to study the safety and effectiveness of these treatments.”
Called REGEN-COV2, the treatment is designed to mimic a well-functioning immune system and uses potent antibodies to neutralise the novel coronavirus.
Patrizia Cavazzoni, Acting Director of the FDA’s Center for Drug Evaluation and Research, said: “The emergency authorisation of these monoclonal antibodies administered together offers health care providers another tool in combating the pandemic. We will continue to facilitate the development, evaluation and availability of COVID-19 therapies.”
The EUA directly relates to the treatment of mild to moderate COVID-19 in adults and paediatric patients with positive results of direct SARS-CoV-2 viral testing and who are at high risk for progressing to severe COVID-19. This includes those who are 65 years of age or older or who have certain chronic medical conditions.
Conor Kavanagh
