The United States drug regulatory agency (FDA) granted this Monday a temporary authorization for a new type of treatment against covid-19, synthetic antibodies manufactured by Eli Lilly, only for mild or moderate patients.
The treatment has been developed specifically against the new coronavirus. Others, such as remdesivir and dexamethasone, received authorizations after having shown some efficacy against the pathogen, but their molecules already existed before the pandemic and had other uses.
The FDA gave an “authorization for emergency use” of the new treatment, based on the results of a clinical trial conducted with 465 non-hospitalized adults.
The US company Eli Lilly had requested the go-ahead from the regulatory agency just over a month ago.
The antibodies can only be used with adults and young people over 12 years of age, weighing at least 40 kg, and who have “a high risk of evolving into a severe covid-19 and / or hospitalization.”
The treatment called bamlanivimab is given as a single injection into a vein. These antibodies mimic what the immune system does after infection with the coronavirus, blocking the tip of the virus that allows it to adhere to and penetrate human cells.
This treatment is considered to be most effective in the initial phase of infection, when the antibodies still have a chance to stop the virus, and not during the second phase of covid-19, in which the danger is no longer the pathogen but an overreaction of the immune system, which attacks the lungs and other organs.
In the clinical trial, only 3% of patients at high risk for severe COVID-19 had to be hospitalized or went to the emergency room after receiving bamlanivimab, compared to 10% who were given a placebo.
ico / cjc / gma / dga