In a move that will allow tens of thousands of vulnerable patients to receive the treatment this winter, the UK medicines regulator (The Medicines and Healthcare products Regulatory Agency) has become the first to approve an oral antiviral pill for Covid.
Molnupiravir is an oral medication you can take twice a day at home.
It will be delivered to approximately half a million Covid patients by mid-November.
Patients with weakened immune systems and those at greater risk, such as the elderly, will receive first.
A national study will be conducted by the NHS to see the drug’s full effectiveness.
MHRA’s decision amounted to a watershed moment in the fight against the pandemic, said Peter Horby, co-leader of a landmark trial at the University of Oxford of Covid treatments.
On Thursday, MHRA announced that the medication, created by Ridgeback Biotherapeutics and Merck Sharp and Dohme (MSD), had been found to significantly reduce hospitalizations and fatalities among people who suffer from mild to moderate Covid and are at increased risk of suffering serious complications.
Sajid Javid, the health secretary, called it a “historic day”, adding “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 groundbreaking treatment.”
No 10 announced last month that it had struck a deal to purchase 480,000 tablets of molnupiravir, also known as Lagevrio, following a US clinical trial showing that the tablets reduced hospitalization or death rates by half among at-risk patients. Mid-November is the earliest date for the first delivery.
In addition, molnupiravir inhibits the virus’ ability to reproduce, resulting in less chance of it multiplying and reaching high levels in the respiratory system, and causing illness.
Due to its high effectiveness when administered early with an infection, it is advised to use it within five days after a positive Covid test and as soon as possible after symptoms appear.
Molnupiravir can be used to treat people with mild to moderate COVID, as well as at least one risk factor for developing a serious illness, such as obesity, diabetes, heart disease, or being over 60 years old.
“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,” Dr. June Raine, the MHRA chief executive explained.
“Lagevrio is another therapeutic to add to our armoury against Covid-19. It 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 of a hospital setting before Covid-19 has progressed to a severe stage.”
Horby recently said: ‘‘The approval of an oral antiviral for Covid-19 is a major scientific achievement and, to me, feels like a bit of a watershed. The MHRA is to be commended for, once again, moving very quickly to ensure the UK population gets access to drugs with proven benefits.
“We do, however, have some more work to do, such as ensuring access and affordability, avoiding drug resistance, and seeing if this drug can benefit other patient groups such as those hospitalized with Covid-19.”
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