The Food and Drug Administration (FDA) has accelerated the approval of Regeneron for the administration of the synthetic antibodies casirivimab and imdevimab for the treatment of patients with mild to moderate coronary symptoms. These are people who have tested positive and are at high risk of developing serious symptoms. President Donald Trump received the medication when he had corona.
The US regulator can give the green light to the use of drugs in an emergency before they have gone through an official and lengthy approval process. According to the FDA, clinical studies have shown that patients who are at high risk of becoming seriously ill are less likely to end up in the hospital or emergency room when given the medication than those on placebo. The funds are injected through an IV.
Casirivimab and Imdevimab are not approved for patients who have been hospitalized for Covid-19 or who are receiving oxygen for the lung virus. They have not been shown to improve upon administration and their condition may worsen with administration if they are ventilated or given oxygen.
“The FDA remains committed to promoting the country’s public health during this unprecedented pandemic. The approval of these monoclonal antibody therapies can help outpatients avoid hospital stays and relieve our health system, “said FDA Commissioner Stephen M. Hahn. “As part of our coronavirus treatment program, the FDA is making every effort to make new treatments available to patients as quickly as possible while investigating the safety and effectiveness of these treatments.”
A similar corona treatment from pharmaceutical company Eli Lilly received emergency approval for use from the FDA on Nov. 9. This antibody therapy would also result in fewer hospitalizations for people who have contracted the coronavirus.
After his infection, Trump was treated with synthetic antibodies from the American company Regeneron, among other things. He believed that the experimental drug should be approved as soon as possible so that it can be used in American hospitals.