Denmark on Thursday approved Merck & Co Inc’s molnupiravir antiviral pill for COVID-19 patients at risk of serious illness, including the elderly.
The treatment is still under review by the European Medicines Agency (EMA). Faced with rising coronavirus cases, the EU drug regulator issued advice in November on using it for adults ahead of providing any wider recommendation.
Announcing its approval for restricted use in Denmark, Health Authority chief medical officer Kirstine Moll Harboe said: “We believe that the benefits of being treated (with it) outweigh the disadvantages for those patients who are most at risk of becoming seriously ill with COVID-19.”
Britain last month became the first country to approve the treatment, jointly developed with Ridgeback Biotherapeutics and for which Merck says it has signed deals totalling more than 7 million courses.
The EMA has recommended that patients begin treatment with the Merck tablet – branded as Lagevrio in the EU – within five days of first symptoms for adults who do not need oxygen support and are at risk of their disease worsening.
Recent trial data however showed the drug only reduced hospitalisations and deaths among high-risk patients by around 30%.
The EU regulator has also begun a review of Paxlovid, a rival antiviral tablet from Pfizer that the company said last month cut by 89% the chance of hospitalisation or death for adults at risk of a severe infection.
That pill could secure U.S. regulatory approval by the end of this year.
Photo – An undated handout photo made available by Merck Sharp & Dohme Corp., shows experimental COVID-19 treatment pills called molnupiravir. EPA-EFE/HANDOUT