LONDON – The United Kingdom has become the first country to approve Merck’s COVID-19 pill.
According to The Associated Press, the U.K. Medicines and Healthcare Products Regulatory Agency issued a conditional authorization Thursday for molnupiravir, the drug developed by Merck and Ridgeback Biotherapeutics. It’s the first pill that has shown success in treating COVID-19, the AP reported.
“Molnupiravir has been authorized for use in people who have mild to moderate COVID-19 and at least one risk factor for developing severe illness,” the government agency said in a news release, adding that regulators had conducted “a rigorous review” of the treatment’s safety and efficacy.
U.K. health officials said patients should seek the treatment “as soon as possible following a positive COVID-19 test and within five days of symptoms onset,” the release said.
British officials said in October that they had secured 480,000 courses of molnupiravir and hope to make the treatment available to patients this winter, according to the AP.
The pill has not yet been approved in the United States. Merck and Ridgeback submitted an application last month to the U.S. Food and Drug Administration seeking emergency use authorization for the treatment.
The U.K.’s move came just weeks after the companies said early results from their Phase 3 clinical trial showed that molnupiravir reduced the risk of hospitalization or death from the illness by about half in the study’s participants, who had underlying health conditions that put them at a higher risk of developing severe COVID-19.
The study tracked 775 adults who had mild to moderate COVID-19 infections and who began treatment with molnupiravir within five days of experiencing symptoms, according to an Oct. 1 news release. Through the 29th day of treatment, about 7% of patients who received the drug were hospitalized or died due to COVID-19, compared with 14% of patients who received a placebo, the release said. No deaths were reported in people who received molnupiravir, while eight deaths were reported in patients who got placebos, the companies said.
The study has not yet been peer-reviewed.
Last week, Merck announced it had signed a voluntary licensing agreement with the Medicines Patent Pool, a U.N.-backed public health organization, to let other drugmakers produce its pill. The move could help lower-income countries get better access to the treatment, the AP reported.
– The Associated Press contributed to this report.
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