The medicine pill is visible with the Merck logo displayed on the screen in the background in this photo taken in Poland on October 4, 2021.
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LONDON – An antiviral pill that has proven to be effective in treating Covid-19 was approved by the UK drug regulator on Thursday, potentially changing the rules of the game in treating the virus.
The British Medicines Regulatory Authority said it approved the world’s first antiviral oral pills known as molnupiravir, deeming them “safe and effective in reducing the risk of hospitalization and death for people with mild to moderate Covid-19 who are at increased risk of infection. a serious illness develops. ” The UK became the first country to approve the drug.
The tablet, co-developed by Ridgeback Biotherapeutics and Merck, inhibits viral replication. This prevents it from multiplying, keeping levels of the virus in the body low and therefore reducing the severity of the disease, the UK Medicines and Health Products Regulatory Agency said. It can also be administered outside the hospital.
The MHRA said the decision “follows a rigorous review of its safety, quality and efficacy” and made it “the first approved oral antiviral for the treatment of Covid-19.”
According to clinical trials, oral tablets are most effective when taken in the early stages of infection. As such, the British regulator recommended using it as soon as possible after testing positive for Covid and within five days of the onset of symptoms.
Antiviral pills are approved for use in people with mild to moderate Covid and at least one risk factor for serious diseases such as obesity, diabetes or heart disease, and for anyone over the age of 60.
UK Health Minister Sajid Javid said it was “a historic day for our country as the UK became the first country in the world to approve an antiviral drug that can be taken at home for COVID-19.”
“This will be a game changer for the most vulnerable and immunocompromised people who will soon be able to receive innovative treatment,” he said in a statement.
MHRA Executive Director June Rein said the pill would greatly facilitate the treatment of Covid, a virus that has hospitalized millions of people around the world and places a huge strain on health services and medical staff.
More than 5 million people have now died from Covid-19 worldwide.
“After careful examination of the data by our experienced scientists and clinicians, we have verified that Lagevrio (molnupiravir) is safe and effective for those at risk of developing severe Covid-19 disease, and have given our approval,” she said.
“Lagevrio is another drug that can be added to our arsenal against Covid-19. It is also the world’s first approved antiviral drug for this disease that can be taken by mouth rather than given intravenously. This is important because it means that it can be administered outdoors. in the hospital until Covid-19 passed into a severe stage, ”she said.
Merck and Ridgeback Biotherapeutics said internal data indicated that the risk of hospitalization or death from Covid has been halved with lightnupiravir. Patients take four tablets twice a day for five days…
Merck shares rose 3% on Thursday ahead of the market open.
– CNBC’s Rich Mendes provided the coverage for this story.