Denmark first EU country to allow Merck pill

The anti-Covid molnupiravir treatment from the American laboratory Merck was authorized for at-risk patients with symptoms on Thursday by Denmark, which becomes the first country in the European Union to give the green light.

This drug, marketed under the name Lagevrio, which comes in the form of tablets, was approved in mid-November by the European regulator for emergency use, before its formal marketing authorization.

“The advantages outweigh the disadvantages”

Lagevrio has been authorized since November in the United Kingdom and in the process of authorization in the United States, but its less good than expected results are pushing countries to wait. “We recommend treatment with tablets because we believe that the advantages outweigh the disadvantages for patients who have the greatest risk of becoming seriously ill from Covid-19”, announced an official of the National Health Agency ( SST), Kirstine Moll Harboe, in a statement.

“We are fully aware that this is a new and unapproved treatment on which we do not yet have much knowledge,” admitted SST ensuring that the effects of the treatment are closely monitored. The announcement comes as Denmark is firing on all cylinders in the face of a record spate of Covid-19 cases and an outbreak of the new variant Omicron, which is expected to become dominant in Copenhagen this week.

Lower efficiency than advertised

The daily number of new cases stood at 8,770 on Wednesday, the highest figure ever reported for the 5.8 million inhabitants. “We hope that the treatment will help reduce the number of hospitalizations in patients at high risk of serious illness,” added Kristine Moll Harboe. In Denmark, 508 people are currently hospitalized, 66 of them in intensive care. The complete results of the clinical trial communicated on November 26 by Merck / MSD show a much lower efficacy than that announced with great noise in early October on the basis of interim data.

According to these comprehensive results, the drug reduced by 30% – not half as initially advertised – the rate of hospitalization and death in at-risk patients who took it soon after infection. On December 9, France refused to authorize the treatment, not deeming it sufficiently effective. Norway signed a bilateral agreement with Merck on Wednesday to ensure prompt deliveries of the treatment, but is still awaiting the green light from the EMA to approve it.