Coronavirus: UK regulator clears first covid-19 antiviral pill for use
The UK's Medicines and Healthcare products Regulatory Agency has cleared the drug Lagevrio for use in treating mild to moderate cases of covid-19.
For the first time since the global coronavirus pandemic began a pill has been authorized as a treatment for covid-19 patients. The United Kingdom’s health regulator has given the green light to an antiviral drug known as Lagevrio (molnupiravir), which was developed by US pharmaceutical firms Merck Sharp & Dohme (MSD) and Ridgeback Biotherapeutics.
An "historic day" in the fight against covid-19
We have just authorised the first oral antiviral for #COVID19, Lagevrio (molnupiravir).— MHRAgovuk (@MHRAgovuk) November 4, 2021
This follows a rigorous review of its safety, quality and effectiveness.
Find out more: https://t.co/B9Lm4U0Xzp pic.twitter.com/q5LNpsl2zP
The UK Medicines and Healthcare products Regulatory Agency (MHRA) said in a statement on Thursday that Lagevrio is “safe and effective at reducing the risk of hospitalisation and death in people with mild to moderate covid-19 who are at increased risk of developing severe disease.” British Secretary of State for Health and Social Care Sajid Javid lauded the news as an “historic day” for the UK, stating that the achievement made it “the first country in the world to approve an antiviral that can be taken at home for covid-19.”
According to the MHRA, molnupiravir “reduces the risk of serious illness or death from covid-19 by approximately 50%.” Javid added that despite the breakthrough, the most important factor is to step up protection measures against contacting covid-19 and called on the British public to continue to take advantage of the government’s vaccination program. Lagevrio was approved following a “a rigorous review of its safety, quality and effectiveness,” by the MHRA and an independent expert scientific advisory body, the Commission on Human Medicines.
Antiviral should not be used "as a substitute for vaccination"
However, the antiviral should not be used as “a substitute for vaccination,” warned researcher Munir Pirmohamed of the Commission on Human Medicines. Clinical trials have shown that Lagevrio is most effective when administered during the early stages of infection, and as such has been recommended for use “as soon as possible following a positive covid-19 test and within five days of symptoms onset.”
The phase III clinical trials were undertaken by 775 patients who had recently been infected with covid-19. Of this group, only 7.3% were hospitalized, compared to 14.1% of the control group who received a placebo. The drug has also displayed sustained effectiveness against the Delta, Gamma and Mu variants.
“We are working at pace across the government and with the NHS to set out plans to deploy molnupiravir to patients through a national study as soon as possible,” Javid said.
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