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Home Coronavirus Treatment authorization for covid-19 unleashes criticism in France

Treatment authorization for covid-19 unleashes criticism in France


Human cell heavily infected with SARS-COV-2 virus particles, isolated from a patient sample, captured at the NIAID Integrated Research Facility (IRF) in Fort Detrick, Maryland – National Institute of Allergy and Infectious Diseases / AFP / Files

The temporary authorization in France of a treatment for covid-19, based on a synthetic antibody from the American pharmaceutical laboratory Eli Lilly, has generated criticism from the medical community, due to the lack of definitive evidence on its effectiveness.

“The seriousness of the situation does not justify stopping the search for the evidence” necessary to authorize a treatment, lamented the French Society of Pharmacology and Therapeutics (SFPT).

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The drug is part of the family of monoclonal antibodies, which are not yet marketed in the European Union. Donald Trump received this type of treatment, manufactured by Regeneron, when he contracted the covid in October.

It is a promising pathway as an early treatment to try to avoid hospitalization and the visit to the intensive care service among the people most vulnerable to the coronavirus.

“It is a new hope (…) that reinforces our anti-virus arsenal”, declared the French Health Minister, Olivier Véran, at the end of February.

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Eli Lilly’s treatment, bamlanivimab, is administered as a single injection at the hospital, costing about 1,000 euros a dose ($ 1,200).

In France, it will be administered “with caution” to “patients from the age of 80, with immunity problems”, according to the minister.

However, bamlanivimab is controversial.

“No to the authorization of unproven treatments”, protests the citizen association Citizen4Science online.

“The results currently and publicly available (…) do not allow to recommend” this treatment, corroborates the SFPT, emphasizing that this antibody has not reached stage 3, the last of large-scale clinical trials.

The Company also points out that the results obtained in phase 2 are also not conclusive.

This treatment is relevant “at an individual level” for vulnerable people, with “strict monitoring”, says, however, Brigitte Autran, coordinator of the group on monoclonal antibodies of the national agency ANRS / Infectious Diseases, based on preliminary results.

The objective is “to move towards a panoply of antibodies, based on the same principle as bi or triple therapies for AIDS”, he explained to AFP.

In turn, Regeneron’s treatment uses two monoclonal antibodies (casirivimab and imdevimab).

The European Medicines Agency estimated on February 26 that this cocktail could be used in patients at risk of becoming seriously ill who do not need intensive oxygen therapy.

Mathieu Molimard, professor of pharmacology and member of the SFPT, also highlights the risk that, because it is based on a single antibody, bamlanivimab may favor the appearance of variants of the coronavirus, due to insufficient efficacy.

Therefore, it is recommended to wait for the development of treatments of the same type, but with the combination of several antibodies.

According to Autran, the Eli Lilly antibody and Regeneron antibodies work against the British variant.

On the other hand, the former is not effective against the South African strain and only one of the two deaRegeneron manages to fight it.

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Source link
https://istoe.com.br/autorizacao-de-tratamento-para-a-covid-19-desata-criticas-na-franca/


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