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It has been announced that molnupiravir, the first pill designed to treat COVID-19, has been approved by the Medicines and Healthcare products Regulatory Agency (MHRA).
The new pill, which is to be taken twice a day, will be prescribed to vulnerable, symptomatic patients who have recently been diagnosed with coronavirus. The drug had originally been developed to treat the flu, but clinical trials found that the drug cut the risk of hospitalisation or death by half.
In a statement, Health Secretary Sajid Javid described the drug as a “gamechanger”, adding: “Today is a historic day for our country, as the UK is now the first country in the world to approve an antiviral that can be taken at home for Covid.”
The national clinical trial saw molnupiravir tested on 775 patients who had recently caught COVID-19. Of those, 7.3% were hospitalised compared to 14.1% of patients who were given a placebo. Of those given molnupiravir, none died but there were eight deaths in the group given a placebo. It was also found that to the drug was most effective when taken within five days of symptoms appearing.
The UK has agreed to purchase 480,000 courses from the manufacturer, Merck, Sharp and Dohme (MSD) who developed the drug with Ridgeback Biotherapeutics. The first deliveries are expected to start arriving this month and will be prescribed to both vaccinated and unvaccinated patients as part of a national study. The decision to order more will be based on the success of the study.
The MHRA have authorised the treatment for use in people who have “mild to moderate” Covid and at least one risk factor such as obesity, diabetes, old age or heart disease.
“It is the world’s first approved antiviral for this disease that can be taken by mouth rather than administered intravenously, says MHRA chief executive, June Raine. “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 USA’s FDA is set to decide whether or not to approve the drug by the end of the month, while Australia, South Korea and several other countries have signed purchase agreements. Pfizer and Swiss company Roche are also working on developing their own pills.
