The European Medicines Agency (EMA) has told EU member states they can now use an antiviral pill to treat Covid-19 in emergency cases.
The drug Lagevrio, also known as molnupiravir, is produced by MSD – known as Merck in the US and Canada – should be administered as soon as possible after diagnosis of Covid-19 and within 5 days of the start of symptoms, the EMA said in a statement.
The EMA’s human medicines committee (CHMP) determined that 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.
It will be the first drug of its kind used in Europe for the treatment of patients with the disease.
The medicine, which is available as capsules, should be taken twice a day for five days. The medicine should not be used to treat pregnant women or women “who can become pregnant and are not using effective contraception”, the EMA said.
“Breastfeeding should be interrupted during treatment and for four days after treatment. These recommendations are given as laboratory studies in animals have shown that high doses of Lagevrio can impact the growth and development of the foetus,” the statement continued.
The 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”.
A study on patients with at least one underlying condition putting them at risk of severe Covid-19 found the drug reduced the risk of hospitalisation and death when treatment started within 5 days of the start of symptoms.
“About one month after treatment started, 7.3pc of patients who took Lagevrio compared with 14.1pc of patients who took a placebo had been hospitalised or had died; none of the patients in the Lagevrio group died compared with eight patients in the placebo group.
“In terms of safety, the most common side effects reported during treatment and within 14 days after the last dose of Lagevrio were diarrhoea, nausea, dizziness and headache, all of which were either mild or moderate,” the EMA said.
The agency said that a rolling review of the drug is ongoing ahead of a possible application for a marketing authorisation for widespread use across the EU.