The EU’s drug regulator has backed the emergency use of Merck’s pill for the treatment for clinically vulnerable Covid-19 patients as cases surge across the continent.
On Friday, the European Medicines Agency (EMA) “Issued advice” backing the emergency use of the drug developed by Merck in collaboration with Ridgeback Biotherapeutics, although it has not yet been authorized by national authorities.
In a statement, the drug regulator said the medicine called Lagevrio – also known as molnupiravir or MK 4482 – “Can be used to treat Covid-19 in adults who don’t require oxygen supplementally and are more at risk for severe Covid-19.”
The treatment must be started as soon as Covid-19 has been diagnosed. It should also be initiated within 5 days. For five days, the medicine should be taken two times daily.
The potential side effects that the capsules could cause include mild to moderate diarrhea, nausea and dizziness, headache, as well as mild to severe dizziness. Pregnant women should not use the treatment.
The watchdog announced earlier on Friday that it had begun reviewing Pfizer’s medicine Paxlovid for Covid-19 with the same goal “To support the national authorities” who may decide on its early use prior to marketing authorization in light of rising cases and deaths in Europe.
On Friday, Austria announced it would enter a new nationwide lockdown from Monday and make vaccination mandatory, while Germany’s health authorities claimed the country had turned into “one big outbreak.”
Merck and Pfizer have both requested FDA approval of their coronavirus medications from the US Food and Drug Administration. However, it’s not clear when this might happen.
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