The UK has become the first country in the world to approve an oral antiviral that can be taken at home to treat Covid-19, it has announced.
The Medicines and Healthcare Products Regulatory Agency (MHRA) now issues a stamp of approval for the use of a drug called Lagevrio (molnupiravir) to treat people with mild to moderate Covid-19, which is considered a risk. in severe illness.
“It could be a gamechanger for the most vulnerable and immunosuppressed, who will soon receive ground-breaking treatment”
Sajid Javid |
According to the MHRA, it is the first antiviral for the treatment of Covid-19 approved to be taken by mouth rather than administered intravenously, which, importantly, means it can be administered outside of the hospital setting prior to severe Covid-19 progressed.
Health and social care secretary Sajid Javid described the move as a “gamechanger” for the most vulnerable and immunosuppressed, and suggested that the government and the NHS work together to “make plans” on how to be treated. of Covid-19. in patients.
Clinical trial results found that the drug reduced the risk of hospitalization or death for at-risk, non-hospitalized adults, with mild to severe Covid-19, by 50%.
Additional data suggest that it is most effective when taken in the early stages of infection and therefore the MHRA recommends that it be used as soon as possible after a positive Covid-19 test, and within five days of symptoms. .
Molnupiravir is approved for use for individuals with mild to moderate Covid-19, who have at least one significant risk for developing serious illness, such as obesity, old age, diabetes or heart disease.
Developed by Ridgeback Biotherapeutics and Merck Sharp and Dohme (MSD), the drug helps lower virus levels in the body, and therefore reduce the severity of the disease, by interfering with virus replication.
The secretary of health and social care says 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-19 “.
“It’s a gamechanger for the most vulnerable and immunosuppressed, who will soon receive ground-breaking treatment,” Mr Javid said.
He added that the government was working with the NHS to “make plans to send molnupiravir to patients through a national study as soon as possible.”
The new treatment is not intended to be used as a replacement for a Covid-19 vaccine.
“We are satisfied that molnupiravir is safe and effective for those at risk of developing severe Covid-19 disease”
Mr Javid added: “This antiviral could be a very good addition to our armory against Covid-19, and it remains important that everyone comes forward for their life-saving Covid-19 vaccine-more already those who qualify for a booster – to make sure more people are likely to be protected in the coming months. ”
Meanwhile, Dr June Raine, chief executive of MHRA, said: “After a rigorous review of the data by our expert scientists and clinicians, we are satisfied that Lagevrio (molnupiravir) is safe and effective for at -risk develop severe disease of Covid-19. and give its consent.
“Without compromising on quality, safety and effectiveness, the public can be confident that the MHRA is conducting a robust and thorough analysis of the data.”
Professor Sir Munir Pirmohamed, chairman of the Commission on Human Medicines, explained that his organization and the Covid-19 Therapeutics Expert Working Group “independently reviewed the data and endorsed the approval of MHRA regulation” on treatment.
“In clinical trials, Lagevrio has been found to be effective in reducing the risk of hospitalization or death for at-risk outpatient adults with mild to moderate Covid-19 by 50%,” he said.
“Based on this and other data carefully reviewed by the commission and its expert team, it is clear that Lagevrio is yet another safe and effective treatment to help us in our fight against Covid-19.”