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WASHINGTON | On Monday the United States Medicines Agency (FDA) granted temporary authorization for a new type of treatment against COVID-19, synthetic antibodies produced by Eli Lilly, for mild and moderate patients only, and not for hospitalized patients or oxygen.
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The treatment was specially developed against the new coronavirus. Others, such as remdesivir and dexamethasone, received varying levels of clearance after showing some efficacy, but these molecules existed before the pandemic and have been reused against COVID-19.
Just over a month after the American Eli Lilly’s request, the FDA granted the new treatment an “authorization for urgent use”, based on the results of a clinical trial carried out on 465 outpatient adults.
It is reserved for adults and children over 12 years of age, weighing at least 40 kg and who have “a high risk of progressing to severe COVID-19 and / or hospitalization”.
The treatment, bamlanivimab, is given as a single intravenous injection. President Donald Trump received a similar treatment in early October, a cocktail of “monoclonal” antibodies developed by the American company Regeneron and which he praised widely after his recovery.
These antibodies mimic what the immune system does after infection with the coronavirus, blocking the tip of the virus that allows it to attach to and enter human cells.
It is considered most effective during the early stage of infection, when antibodies still have a chance to control the invader, and not during the second stage of COVID-19, when the virus is no longer in danger. same, but the overreaction of the immune system that attacks the lungs and other organs.
In the clinical study, bamlanivimab reduced the proportion of patients hospitalized or going to the emergency room within 28 days of injection: 3% in the group of patients treated, compared to 10% in the group of patients who received a placebo.
This authorization will allow American hospitals and doctors to use the treatment outside of clinical trials, but still in an environment that allows them to respond to any severe allergic reactions such as anaphylactic shock.
But this is not a permanent authorization: it only lasts during the pandemic emergency, and can be revoked later.
Data is limited, but the rationale for emergency clearance is to lower the usual scientific evidence threshold to add a weapon to the arsenal of responses to the health crisis, the FDA estimates that the risks of serious secondary effects are limited. .
“It is reasonable to assume that the known and potential benefits of bamlanivimab (…) outweigh the known and potential risks,” FDA Chief Scientific Officer Denise Hinton wrote in the authorization letter.
The antibody treatment will allow the United States to “hold out until the release of safe and effective vaccines,” said Health Secretary Alex Azar, who expects the first vaccines later this year.
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