Denmark first in EU to authorise Merck COVID pill

Denmark on Thursday recommended US drugmaker Merck's anti-COVID treatment molnupiravir for at-risk patients with symptoms, becoming the first EU country to do so.

The pill-based treatment, marketed under the name Lagevrio, was backed for emergency use by the European Medicines Agency (EMA) in mid-November, allowing individual EU countries to decide for themselves whether to use the pills even before being formally authorised.

Lagevrio has been approved since November in the UK and is in the process of being approved in the US.

"We are recommending the pill treatment because we believe that the benefits outweigh the harms for those patients who are most at risk of becoming severely ill with COVID-19," Kirstine Moll Harboe at the Danish Health Authority said in a statement.

"At the same time we are fully aware that this is a new and unapproved treatment about which we do not yet have much knowledge."

Moll Harboe said the effects of the treatment would be closely monitored.

Denmark is suffering from a record wave of COVID-19 cases and an outbreak of the new Omicron variant, which is expected to become the dominant strain in Copenhagen this week.

On Wednesday, 8,770 new cases were reported, the highest figure for the 5.8 million population since the start of the pandemic.

"We hope that the treatment will help reduce the number of hospital admissions for patients at high risk of severe disease," Moll Harboe said.

In Denmark, 508 people diagnosed with COVID-19 are currently in hospital, 66 of them in intensive care.

The full results of the clinical trial released on November 26 by Merck were disappointing as they showed a much lower efficacy than earlier reports based on interim data.

According to the full results, the drug reduced the rate of hospitalisation and death for at-risk patients who took it shortly after infection by 30 percent—not 50 percent as previous results showed.

© 2021 AFP