Hydroxychloroquine: end of refusal of the drug Agency to Professor Raoult

There is no question of widely authorizing hydroxychloroquine in France against Covid-19: the Medicines Agency (ANSM) has refused Pr Didier Raoult a more extensive use of this molecule, which has still not demonstrated its effectiveness. efficiency.

"We cannot respond favorably to the request for RTU (temporary recommendation for use, Editor's note) for hydroxychloroquine in the management of Covid-19 disease", indicates the ANSM in an information point. online on its website Friday.

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"To date, the available data, which are very heterogeneous and uneven, do not allow us to predict a benefit from hydroxychloroquine, alone or in combination, for the treatment or prevention of Covid-19 disease", -she. 

Didier Raoult denounces a "double standard" 

Hydroxychloroquine is marketed in France by the Sanofi laboratory under the name Plaquenil, but for other diseases such as rheumatism or certain lupus.

The prescription by a doctor of a drug outside the indications provided for by the marketing authorization (MA) must be done "on a case-by-case basis", informing the patient of the risks incurred and of non-reimbursement, and the mention "non-AMM" must appear on the prescription.

The temporary recommendation for use (RTU), which gives access to reimbursement, aims for a massive prescription outside the MA, beyond the prescription on a case-by-case basis.

Hence the request for the Institut hospitalo-universitaire (IHU) Méditerranée Infection, directed by Didier Raoult, who has a large number of patients.

A "double standard", reacted Didier Raoult on Twitter after this refusal, accusing the ANSM of promoting the antiviral remdesivir (Gilead) to the detriment of hydroxychloroquine.

The health agency specifies that "this position could be revised" if it was provided with new convincing clinical studies.