The move was made in light of rising Covid rates across the EU.
Pharmaceutical company Merck’s anti-covid pill has been given the green light for emergency use in EU countries by the European Medicines Agency (EMA).
Though the pill, also known as molnupiravir, is not authorised in the EU yet, the EMA issued advice on its use in order to support countries that wish to roll it out in emergency cases, given the recent Covid wave in Europe.
“The medicine, which is currently not authorised in the EU, can be used to treat adults with Covid-19 who do not require supplemental oxygen and who are at increased risk of developing severe Covid-19.
“EMA issued this advice to support national authorities who may decide on possible early use of the medicine prior to marketing authorisation, for example in emergency use settings, in light of rising rates of infection and deaths due to Covid-19 across the EU.”
‼️ EMA issues advice to support 🇪🇺 countries who may decide on early use of the oral antiviral molnupiravir.
The #medicine can be used to treat adults with #COVID19 who don’t require supplemental oxygen and who are at increased risk of severe disease.
👉https://t.co/cx6Bp26uFK pic.twitter.com/SfkvKvErQG
— EU Medicines Agency (@EMA_News) November 19, 2021
Molnupiravir works by increasing the number of mutations in the virus’ genetic material, impairing its ability to multiply.
The drug should be administered as soon as possible after the diagnosis of Covid-19 and within five days of the start of symptoms.
The EMA said its advice follows a review of data on the medicine’s quality and results from completed and ongoing studies.
Interim results from the main study in non-hospitalised, unvaccinated patients with at least one underlying condition found that the pill, when given at a dose of 800 mg twice a day, reduced the risk of hospitalisation and death when treatment started within five days of symptoms starting.
The EMA said that the most common side effects reported during treatment and within 14 days after the last dose of the drug were diarrhoea, nausea, dizziness and headache, all of which were either mild or moderate.
It also stated that the pill is not recommended to be taken during pregnancy and for “women who can become pregnant and are not using effective contraception”.
The EMA said this advice was given “as laboratory studies in animals have shown that high doses of [the Merck pill] can impact the growth and development of the foetus”.
A more comprehensive rolling review of the pill is continuing, the EMA added, ahead of a possible application for marketing authorisation.
Separately, the drug watchdog has also said it is currently reviewing available data on the use of Paxlovid, an oral treatment for Covid-19 developed by Pfizer, so that it could give similar advice regarding its use.
“Authorities in the EU remain committed to expediting the evaluation of much needed Covid-19 treatments and vaccines, while ensuring these meet the EU’s high standards of safety and efficacy,” it said.
‼️ EMA starts a review of Paxlovid, the #COVID19 oral treatment developed by Pfizer, to support EU countries who may decide on its early use for COVID-19 before authorisation.
👉https://t.co/bORg92JkRv #HealthUnion pic.twitter.com/2OmcYZlY2S
— EU Medicines Agency (@EMA_News) November 19, 2021
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