The European Union (EU) drug regulatory body has issued guidance on the use of Merck’s COVID-19 pill for adults and has initiated a review of a Pfizer tablet to help member states decide on its rapid adoption.
In two separate statements on Friday, the European Medicines Agency (EMA) detailed efforts to advance the use of the experimental but promising options, as COVID-19-related infections and deaths are rapidly increasing in the region and forcing new lockdowns.
The EMA said the COVID-19 tablet from Merck, Lagevrio, developed with Ridgeback Biotherapeutics, should be given early and within 5 days of the first symptoms to treat adults who do not need oxygen support and are at risk of worsening their disease.
He advised against treatment during pregnancy and for women planning or likely to become pregnant, while adding that breastfeeding should be stopped around the use of the pill, which should be taken twice a day for five days.
Medicines in the same class as Lagevrio Merck have been linked to birth defects in animal studies.
The drugmaker, known as MSD outside of the United States and Canada, has claimed that animal tests show that its pill is safe, but the data has not been released.
The EMA said he is studying the available data on the Pfizer pill, Paxlovid, days after the pharmaceutical company applied for approval in the United States, adding that a more thorough review is expected to begin before any approval. It did not specify when that review would be.
The EMA started an ongoing review of the pill last month Merck and expects to complete that evaluation by the end of the year.
For its part, Pfizer It applied for authorization this week for the emergency use of its pill in the United States after data showing that it reduced the possibility of hospitalization or death by 89% in adults who are at risk of their disease getting worse.
The pill Merck, approved by Britain earlier this month, has been shown to cut those chances in half when given early in the disease.
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