Denmark on Thursday approved an antiviral COVID-19 drug produced by Merck and Ridgeback Biotherapeutics for at-risk patients with symptoms, including the elderly.
The Scandinavian country became the first in the European Union to approve the antiviral treatment called molnupiravir. The pill is still under review by the European Medicines Agency (EMA).
“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,” she added.
Last month, Britain became the first country globally to approve the treatment that can be taken as a pill at home. Health officials in the United States are in the process of approving it. The pill could secure U.S. regulatory approval by the end of this year.
The drug works by interfering with the virus’ replication and preventing it from multiplying, keeping levels low in the body and therefore reducing the severity of the CCP (Chinese Communist Party) virus, which causes the disease COVID-19.
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 showed the drug reduced hospitalizations and deaths among high-risk patients by around 30 percent, significantly less effective compared to an interim study the U.S. drugmaker previously reported showing an approximate 50 percent reduction.
The EU regulator has also begun a review of PAXLOVID, an experimental antiviral tablet produced by Pfizer Inc., a U.S.-based pharmaceutical company headquartered in New York.
Pfizer said in a Dec. 14 statement that the antiviral treatment is able to reduce the risk of hospitalization or death from the CCP virus by 89 percent when taken shortly after initial symptoms. Antiviral treatments need to be given to patients as early as possible to be most effective, best within days of the onset of symptoms.
Reuters contributed to this report.