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Italian Medicines Agency Agenzia Italiana del Farmaco

COVID-19: AIFA limits the use of remdesivir in selected cases and allows for hydroxychloroquine to be used only in randomised clinical trials in an outpatient setting - COVID-19: AIFA limits the use of remdesivir in selected cases and allows for hydroxychloroquine to be used only in randomised clinical trials in an outpatient setting

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COVID-19: AIFA limits the use of remdesivir in selected cases and allows for hydroxychloroquine to be used only in randomised clinical trials in an outpatient setting

On 26 November 2020, the Italian Medicines Agency published an update, based on the most recent studies, of the fact sheets relating to the use of hydroxychloroquine, remdesivir and heparin for the treatment of COVID-19 patients.

With regard to remdesivir, the Agency established that, in light of the new evidence available, even within the population eligible for reimbursement (patients with COVID-19 pneumonia on oxygen therapy not requiring high-flow oxygen or mechanical ventilation or ECMO, and with symptom onset of less than 10 days), use can only be considered in selected cases, after an accurate evaluation of the benefit/risk ratio.

AIFA confirmed that the off-label use authorisation of hydroxychloroquine was suspended both for therapeutic use (inpatient and outpatient settings) and prophylactic use, on the basis of evidence that has progressively accumulated and which demonstrates a complete lack of efficacy against an increase in adverse events, albeit not serious. Use in patients with a non-serious condition and at early stages of the disease can be allowed only in randomised clinical trials, as evidence is currently limited, but generally negative.

As far as heparins are concerned, the fact sheet was updated with a critical review of the latest evidence in literature, clearly reporting the available efficacy and safety evidence both for prophylactic use and intermediate/high dosage.

The information is contained in the page "Medicines usable for treatment of COVID-19 disease" accessible through the box "Related links".


Published on: 26 November 2020

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