Merck's antiviral pill that fights COVID-19 in adults with the disease won its first authorization in the world Thursday, as the U.K.'s medical regulator announced that the drug is "safe and effective at reducing the risk of hospitalization and death" in mild to moderate cases.
The drug is a "game changer," British Health and Social Care Secretary Sajid Javid said. Merck and Ridgeback Biotherapeutics developed the oral antiviral.
"Today is a historic day for our country, as the U.K. is now the first country in the world to approve an antiviral that can be taken at home for COVID-19," Javid said.
The U.K.'s authorization is based on clinical studies that showed the drug reduced the risk of hospitalization or death by about 50% for at-risk adults with mild to moderate COVID-19 cases.
The drug, which is called molnupiravir and will be sold under the name Lagevrio in the U.K., helps people cope with COVID-19 by interfering with the virus's ability to replicate itself.
"This prevents it from multiplying, keeping virus levels low in the body and therefore reducing the severity of the disease," the U.K.'s Medicines and Healthcare products Regulatory Agency, or MHRA, said.
"Lagevrio is another therapeutic to add to our armory against COVID-19," said MHRA Chief Executive Dr. June Raine. "It is also the world's first approved antiviral for this disease that can be taken by mouth rather than administered intravenously. This is important, because it means it can be administered outside of a hospital setting, before COVID-19 has progressed to a severe stage."
The drug works best when taken soon after infection
Because of its ability to tamp down on viral levels in the body, the drug works best when it's taken very soon after infection — preferably within five days of the first symptoms.
The MHRA approved the drug for people who have mild or moderate cases of COVID-19, along with at least one risk factor, such as obesity, heart disease or being 60 or older.
COVID-19 rates are currently high in the U.K. with 1.1 million cases over the past 28 days — the second-most cases in the world (after the U.S.), according to Johns Hopkins University.
In late October, the prevalence of infection rose to 1.72%, or about 1 in 58 people overall, according to interim results of a large study that were released Thursday.
Outside of the U.K., molnupiravir is still being evaluated by the U.S. Food and Drug Administration and the European Medicines Agency, according to Merck.
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