Britain on Thursday became the first country to approve an anti-Covid pill, as it gave the green light for the use of Merck’s antiviral drug to treat patients with mild to moderate coronavirus, regulators 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,” Health Minister Sajid Javid said.
“This will be a game-changer for the most vulnerable and the immunocompromised, who will soon be able to receive the revolutionary treatment,” he added.
The antiviral drug called molnupiravir works by decreasing a virus’s ability to replicate, thus slowing the disease.
The Medicines and Health Products Regulatory Agency (MHRA) said its trials found it to be “safe and effective in reducing the risk of hospitalization and death in people with mild to mild Covid-19. who are at increased risk of developing severe disease “.
Based on clinical trial data, the drug is most effective when taken during the early stages of infection and the MHRA recommends that it be used within five days of symptom onset.
It has been approved for use in people who have at least one risk factor for developing serious illnesses, including obesity, old age, diabetes and heart disease.
Great Britain, which has been one of the countries hardest hit by the pandemic, announced on October 20 that it had ordered 480,000 doses of molnupiravir from the American pharmaceutical giant Merck.
Drug regulators in the United States and the European Union have already started an evaluation of the drug.
Not a vaccine replacement
Merck has already signed agreements with other governments, including the United States, that plan to purchase 1.7 million doses if molnupiravir is approved by regulators.
MHRA Executive Director June Raine called the pill “another therapy to add to our arsenal.”
“It is also the first antiviral approved in the world for this disease that can be taken orally rather than given intravenously,” she added.
“This is important because it means it can be administered outside of a hospital.”
Clinical trials have found the drug to be effective in reducing the risk of hospitalization or death for non-hospitalized at-risk adults by 50%, according to Munir Pirmohamed, chairman of the Human Medicines Commission.
But experts warned the treatment was not a silver bullet, and Pirmohamed said it was not intended to be used as a substitute for vaccination against the virus.
The government said it and the state-run National Health Service would announce the “on-time” rollout of the treatment.
A simple pill to treat the coronavirus has been sought since the start of the pandemic and Merck’s announcement of the results of its trials has been hailed as a major step towards that goal.
Until now, Covid therapies such as monoclonal antibodies and Gilead’s remdesivir – approved for use in the EU under the name Veklury – have been administered intravenously.
Molnupiravir was originally developed as an inhibitor of influenza and respiratory syncytial virus – two other important acute respiratory infections – by a team at Emory University in Atlanta, Georgia.
Merck is also conducting a separate clinical trial for a second use of the drug, to prevent people who have been in close contact with people who carry the virus from developing it.
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