For the first time, the EU’s medicines agency, EMA, has been given an application for approval of a means to treat Covid-19, which is the disease, you can get by infection with the coronavirus.
this was stated by The EMA on its website.
There is talk about the drug Remdesivir, which among other things has been tested on patients in Denmark.
the Danish medicines agency has already made it easier for Danish hospital departments that seek to use the means.
This means that doctors can seek permission to use Remdesivir for the entire department instead of to each individual patient.
the Manufacturer has applied to the EMA for conditional approval of Remdesivir, so there may be attached some conditions to the use of the preparation.
It means, according to EMA’s website that the approval must be renewed each year.
in Addition, there may be increased reporting requirements, so the authorities are quickly aware of any problems.
If the EMA considers that the benefits of using Remdesivir against Covid-19 is greater than the side effects, the agency will recommend that the EUROPEAN Commission provides a hastetilladelse that the drug can be sold in all EU countries.
the Head of EMA, Guido Rasi, has previously indicated that an approval of Remdesivir may be imminent.
In a hearing 18. may for the EUROPEAN Parliament environment and health committee, he said that an approval could take days. Already then was the EMA in time with a continuous treatment of the data from various studies in the use of Remdesivir.
Now, the agency has thus an application, as it can turn the tomlen up or down to.
Remdesivir is a so-called broad-spectrum antiviral drug. It is developed by the u.s. pharmaceutical company Gilead Sciences in 2009.
Remdesivir was originally developed to treat hepatitis and as possible remedy against ebola. But it has also been shown to have an effect against the corona virus.
In studies, the drug has shown that it can reduce mortality and indlæggelsestiden for patients with Covid-19. But it must be given at specific times in the course of the disease.
