As announced at the beginning of the month, the European Medicines Agency (EMA) issued an opinion on Friday 19 November on the emergency use of Lagevrio (molnupiravir or MK 4482), the candidate treatment against Covid-19 that has been developed by the Merck laboratory (see EUROPE 12829/23).
This drug, which has now been under evaluation by the EMA for almost a month, has not yet been granted a European marketing authorisation.
However, since the health situation in the EU is particularly critical, the Agency has published this opinion in order to provide guidance to national authorities who have decided to use Lagevrio without waiting for its formal authorisation. In order to manage a health emergency, for example.
The EMA therefore recommends the use of Merck‘s drug to treat adults with Covid-19 who do not require supplemental oxygen and who present with an increased risk of developing a severe form of the disease.
“Lagevrio should be administered as soon as possible after diagnosis of Covid-19 and within five days of the start of symptoms”, recommends the Agency, although it does advise against its use in pregnant women.
The data that has been reviewed showed that Lagevrio reduced the risk of hospitalisation and death, according to the EMA.
To see the recommendations in detail: https://bit.ly/3oKOxpt
Potential new treatment
Also on Friday 19 November, the European Agency announced that it had started evaluating a new candidate treatment, the ninth since the launch of the European action plan on anti-Covid-19 therapeutic solutions (see EUROPE 12714/11).
This new oral treatment, Paxlovid (PF-07321332/ritonavir), has been developed by Pfizer.
As with Lagevrio, the review of Paxlovid, which began this week, is intended to support national authorities who decide to use it in emergency situations, before a European market authorisation has been issued to the manufacturer. This review should be completed “in the shortest possible timeframe”, says the European Agency.
A more comprehensive rolling review should also begin before Pfizer even applies for a market authorisation, said the EMA. (Original version in French by Agathe Cherki)