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The UK became the first country to approve the oral anti-viral drug Lagevrio (molnupiravir) for Covid-19.

The Medicines and Healthcare products Regulatory Agency (MHRA) has approved the use of the antiviral for Covid-19 following trials which showed it to be effective at reducing the severity of Covid symptoms in people with mild-to-moderate disease and who are at increased risk of developing severe disease.

In trials, Lagevrio was shown to reduce the risk of hospitalisation and death from Covid-19 by up to 50 per cent in at-risk, non-hospitalised adults.

In most cases, antivirals will prevent the virus from developing or reproducing in the body, thus shortening the severity or length of an infection. Lagevrio was originally developed to treat the flu, but trials have been shown to be effective in treating Covid-19.

It works by interfering with the virus’ replication, as molecules of molnupiravir enter virus-infected cells and are converted into a defective version of the building blocks of viral RNA, which means the virus particles’ genetic material becomes defective, and the virus can no longer replicate. Unable to replicate, the viral load is kept low, reducing the risk of developing serious diseases and allowing the immune system time to deal with the virus more effectively.

In the trial, 775 patients who had recently caught Covid-19 were given either Lagevrio or a placebo. In the Lagevrio group, 7.3 per cent of patients were hospitalised with no deaths. In the placebo group, 14.1 per cent of patients were hospitalised, and there were eight deaths. After reviewing the data, the MHRA have advised that Lagevrio is a safe and effective treatment that could change the lives of immunocompromised and otherwise vulnerable patients as the Covid-19 pandemic continues.

Based on the data from the clinical trials, to be most effective, Lagevrio needs to be given to patients in the early stages of infection and targeted at immunocompromised patients who are at higher risk. The MHRA recommends its use as soon as possible following a positive Covid-19 test and within five days of symptoms onset; it is taken twice a day for five days. The MHRA has approved the use of Lagevrio for patients with mild-to-moderate Covid and at least one risk factor, such as old age, diabetes, heart disease or obesity.

The Government and the NHS will confirm how this Covid-19 treatment will be deployed to patients in due course but stress that it is not intended to be used as a substitute for vaccination against Covid-19 and that vaccination is still the most effective way to protect against the disease.

The drug may be offered to care homes and prescribed to vulnerable patients by their GP. The treatment will be given to both vaccinated and unvaccinated patients in the UK at first as part of a national study to gather more data about its effectiveness.

Lagevrio was developed by Ridgeback Biotherapeutics and Merck Sharp & Dohme (MSD). Apart from vaccinations, the other options for treating Covid include medications such as Gilead’s infused antiviral remdesivir and generic steroid dexamethasone. These are generally only given after a patient has been hospitalised. Britain has agreed to a deal with Merck to secure 480,000 courses of Lagevrio.

Health and Social Care Secretary, Sajid Javid, said: “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. This will be a gamechanger for the most vulnerable and the immunosuppressed, who will soon be able to receive the ground-breaking treatment.
“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.”

Dr June Raine, MHRA Chief Executive, said: “Following a rigorous review of the data by our expert scientists and clinicians, we are satisfied that Lagevrio (molnupiravir) is safe and effective for those at risk of developing severe Covid-19 disease and have granted its approval.

“Lagevrio is also the world’s first approved antiviral for this disease that can be taken by mouth rather than administered intravenously. This is important because it means it can be administered outside a hospital setting before Covid-19 has progressed to a severe stage.

“With no compromises on quality, safety and effectiveness, the public can trust that the MHRA has conducted a robust and thorough assessment of the data.”

Rachel Kayani