He Committee for Medicinal Products for Human Use (CHMP) made up of experts from the competent authorities of the different EU member states – including the Spanish Agency for Medicines and Health Products (Aemps) – has concluded that there is “sufficient evidence” to consider the dexamethasone as an “effective alternative” in the treatment of coronavirus in adults and adolescents over 12 years of age with pneumonia that requires oxygen.
Dexamethasone is a corticosteroide that has been used for the treatment of patients with Covid-19 in the context of routine clinical practice and in clinical trials in order to obtain “reliable evidence” of its efficacy against SARS-CoV-2, as the Aemps recalled this Friday. it’s a statement.
The agency pointed out that on July 24, the evaluation of the efficacy and safety data from the Study ‘Recovery’, which includes an arm of patients receiving dexamethasone and whose published data show that when the number of deaths is compared between patients receiving usual clinical care and those receiving dexamethasone, the percentage of patients who die is reduced “significantly due to its use ”.
The results of this study are supported by an analysis made by the World Health Organization (WHO) from global data from seven published clinical trials analyzing the role of corticosteroids in the management of Covid-19.
With all this evidence, the CHMP has concluded that, for the treatment of patients with Covid-19, dexamethasone can be administered by orally or given as an injection or infusion (drip) by intravenously. In all cases, the recommended dose in adults and adolescents is six milligrams once a day for a maximum of 10 days.
Dexamethasone marketing holders may request the inclusion of all information related to the use against Covid-19 by sending a request to national regulatory agencies.