Coronavirus

EU before conditional approval of Remdesivir

The director of the European Medicines Agency, EMA, said remdesivir may be granted a “conditional market approval” in the coming days.

A few days ago, the European Medicines Agency (EMA) expanded its recommendations for the use of remdesivir: It should also be possible to get Covid 19 patients who do not need ventilators.

A clinical trial from the United States had previously shown that remdesivir in Covid 19 patients could reduce the time to recovery by several days.

The European Union appears to be paving the way for the use of the drug remdesivir in Covid-19 patients shortly. The director of the European Medicines Agency (EMA), Rasi, said at a hearing in the EU Parliament in Brussels that a “conditional market approval” could be issued in the coming days.

This would enable the drug to be used in Europe before it is fully approved. The active ingredient developed by the US biotech group Gilead was originally developed against Ebola.

In the United States, Remdesivir has recently been approved for use in emergencies. A few days ago, the European Medicines Agency (EMA) also expanded its recommendations for the limited use of the active ingredient remdesivir for the treatment of severe Covid-19 infections. The EMA said that it can now also be used for certain inpatients who do not need ventilation equipment.

Remdesivir reduces the duration of the illness by several days

A clinical trial from the United States had suggested that administration to Covid patients could shorten the time to recovery by several days.

However, according to the first results, the drug only led to a slightly lower mortality rate. There is also still no reliable information on side effects and which patients are most likely to benefit from treatment.

The EMA is currently evaluating existing data as part of the ongoing review of Remdesivir, it said. According to the EMA recommendation, the agent can now also be used for non-invasive ventilation or if the seriously ill patient is supplied with additional oxygen.

Remdesivir can also be used in Germany in cases of hardship

Remdesivir has not yet been approved as a drug in any country in the world. At the beginning of May, the United States granted an exemption for the limited use of the active ingredient in hospitals. In Germany, too, the drug is accessible within a drug hardship program and is being tested in clinical studies.

So far there is no preventive vaccination against the coronavirus Sars-CoV-2, and there is also no reliable effective approved drug therapy for the disease Covid-19 caused by the virus.

In the EU, a special approval procedure for remdesivir was started on April 30. In this so-called “rolling submission”, the applicant gradually submits data from studies and laboratory tests.

They will then be assessed by the European Medicines Agency, more precisely by the CHMP committee responsible for medicinal products for human use. If the data is complete, the applicant can submit an application for admission. In this way, the approval process should be accelerated.

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