- “The drug, which has not yet been approved in the European Union, can be used to treat adults with COVID-19, who do not need oxygen but are at risk of developing severe disease,” the EMA said in a statement. .
- The agency has advised that Baxlovid should be given as soon as possible after a diagnosis of COVID-19 and within five days of symptoms appearing
- The drug should not be used in patients with severe renal or hepatic impairment, and it should not be given to pregnant women.
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The most common side effects of Baxlovid treatment are taste changes, diarrhea, and vomiting.
The EMA clarifies that recommendations issued prior to the drug being put on the market will be used by regulators in European Union countries to decide on the possible authorization of treatment with this preparation prior to its final approval.
The agency said it was still conducting research on Paxlovid and that it would be brought to market after analyzing new data as it became available.
The EMA also issued recommendations Thursday for the drug Xevudy, which is also recommended to treat adults and adolescents with Covid-19 who do not need oxygen but are at risk of developing a severe form of the disease. Xevudy is produced by GSK and Vir Biotechnology, and is currently used as an immunosuppressive drug.
According to an EMA report, laboratory studies suggest that Xevudy may also be effective in treating infections with the Omikron variant.
This preparation has not been approved by the EMA on the EU market as a medicine for COVID-19, but the agency’s recommendations are guidelines for the authorities of EU countries.
The EMA also recommends the inclusion of adult patients with COVID-19, who are at risk of serious respiratory dysfunction or pneumonia and require the administration of oxygen, the immunosuppressive drug Kineret (anakinra), produced by the Swedish company Sobi. The preparation has been available on the market since 2001.
In November, the EMA issued recommendations for the use of molnupiravir, Merck & Co.’s oral drug. for Covid-19.
The EMA has so far approved three drugs for Covid-19 in the European market. The first – Veklury, which disrupts the production of viral RNA – in July 2020. Two more – Ronapreve and Regkirona, based on monoclonal antibodies – November 11.
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