A monoclonal antibody drug cocktail developed by Regeneron that former US President Donald Trump touted as a “cure” for COVID-19 in October 2020 has received approval from a European Union regulator.
The European Medicines Agency has completed a review of the use of monoclonal antibodies casirivimab and imdevimab for COVID-19 patients who do not require supplemental oxygen and who are at high risk of progressing to severe COVID-19. Monoclonal antibodies are manufactured copies of antibodies created by the human body to fight infections.
“In terms of safety, most side effects reported were mild or moderate, however reactions related to the infusion (including allergic reactions) have been seen and should be monitored for,” the EMA said.
Its recommendation can now be used as guidance in individual European nations.
Following his diagnosis with COVID-19 in September, Trump received an intravenous dose of Regeneron’s dual antibody, along with immune system boosters zinc and vitamin D, aspirin, and other generic drugs.
Though the treatment was unproven at the time, Trump touted it as a “cure” for COVID-19 after his recovery. “It was, like, unbelievable,” he said in a video at the time, adding “I felt good immediately.”
In November, the Food and Drug Administration (FDA) issued emergency use authorisation for the Regeneron cocktail for treatment of mild to moderate COVID-19 in adults who are at high risk of progressing to severe COVID-19. The treatment was not authorised for those who needed oxygen therapy, or for those who were hospitalised due to COVID-19.
The FDA cited the EUA definition of high risk as patients who met at least one of the following criteria: Have a body mass index (BMI) ≥35, have chronic kidney disease, have diabetes, have immunosuppressive disease, are currently receiving immunosuppressive treatment, are ≥65 years of age, are ≥55 years of age and have cardiovascular disease, or hypertension, or chronic obstructive pulmonary disease (COPD)/other chronic respiratory disease, are 12 – 17 years of age AND have BMI ≥85th percentile for their age and gender based on CDC growth charts, or sickle cell disease, or congenital or acquired heart disease, or neurodevelopmental disorders, for example, cerebral palsy, or a medical-related technological dependence, for example, tracheostomy, gastrostomy, or positive pressure ventilation (not related to COVID19), or asthma, reactive airway or other chronic respiratory disease that requires daily medication for control.