<h2>This is Remdesivir, an antiviral under study already authorized for sale in the United States</h2> </p><div> <!-- VIDEO --> <!-- PLAYER VIDEO --> <!-- BEGIN EMBED CODE BC player --> <!-- END EMBED CODE BC player --> <!-- END PLAYER VIDEO --> <!-- FINE VIDEO --> <!-- SOCIAL TOOLBAR -->
<p>The European Medicines Agency (Ema) has announced that it has received the application for authorization <strong>to the conditional marketing for the antiviral drug Remdesivir</strong> as a therapy for coronavirus. The Adnkronos makes it known.
Ema therefore formally launched its assessment. The process will consist in examining the benefits and risks of the drug.
After that the decision will be made on the green light andwithin a few weeks, depending on the solidity of the data presented.
Such a short period of time can be respected because some data have already been evaluated during the first periodic review cycle, started on April 30 and ended on May 15.
In this first phase, Ema’s scientific committees and working groups worked in synergy to complete the dossier evaluation significantly earlier than the standard procedure, while still ensuring a solid assessment of the available data.
At the end of the first cycle of the periodic review, the Committee for Medicinal Products for Human Use of Ema (Chmp) invited the manufacturing company to submit further information, together with the application for conditional marketing authorization.
At the same time, the Ema Security Committee (Prac) completed the initial assessment of the preliminary risk management plan proposed by the company, which outlines the measures to identify, characterize and minimize the risks of the drug.
The Prac will continue to evaluate the safety data of Remdesivir quickly to identify and address potential security issues promptly.
Finally, the Ema committee for pediatric medicines (Pdco) quickly expressed its opinion on the company’s pediatric investigation plan (Pip), which describes how to develop and study the medicine for use in children, in accordance with the accelerated times for products against Covid-19.
If the additional data presented will be sufficient to allow the Chmp to conclude that the benefits of Remdesivir outweigh the risks in the treatment of Covid-19 – continues the Agency – Ema will work closely with the European Commission to quickly issue the marketing authorization from the European Commission in all EU and See member states.
Remdesivir – remember – is an investigational antiviral medicine for the treatment of Covid-19.
It is a viral inhibitor of RNA polymerase and interferes with the production of viral genetic material, preventing the virus from multiplying. It has demonstrated extensive in vitro activity against various Rna viruses, including Sars-Cov-2 and was originally developed for the treatment of Ebola virus disease.
Although it is not yet authorized for marketing in the European Union (but it is in the United States) is already available to patients through clinical trials and compassionate use programs.
VIRGILIO NEWS | 08-06-2020 17:20
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