The health authorities of the United Kingdom have approved the use of first antiviral pill against covid-19, the molnupiravir, which can be used in patients who have tested positive and who have at least one risk factor to develop a serious illness.
The Medicines Regulatory Agency (MHRA) considered in a statement that the drug is “Safe and effective to reduce the risk of hospital admission and death in people with mild to moderate covid who suffer an extra risk.”
“Today is a historic day for our country, because the United Kingdom is now the first country in the world to approve an antiviral against covid-19 that can be taken at home”, Declared the Minister of Health Sajid Javid it’s a statement. “This will change the situation for the most vulnerable and the immunosuppressed, who will soon be able to receive the revolutionary treatment”added.
This drug is recommended, for example, for obese people, over 60 years old and patients with diabetes or with Heart problems.
The MHRA indicated that the drug should be supplied immediately after testing positive for COVID or within five days of confirmation of infection.
Regulators’ recommendation is that the tablet, originally developed to treat the flu, be taken by these vulnerable people twice a day.
The new drug was developed by the North American pharmaceutical company MSD, known as Merck & Co in the United States and Canada together with its North American partner Ridgeback Biotherapeutics, which has already asked the US health authority FDA its approval in emergency use. It is the first drug for the treatment of covid that can be taken in pill form instead of an injection.
The drug attacks an enzyme that the virus uses to make copies of itself, so its multiplication is prevented and the viral load is kept at low levels in the body, thereby reducing the severity of the disease.
The CEO of the British regulator, June raine, rated the drug as “Another therapy for our armor against covid-19”, adding that its approval is important because it can be taken outside of the hospital setting.
Hospitalization or death reduced by 50%
According to the results of the study of Phase 3, the pill reduced the risk of hospitalization or death by approximately 50%. In the interim analysis, 7.3% of patients receiving molnupiravir were hospitalized or died, compared with 14.1% of patients receiving placebo. Previous studies showed that the drug did not help those who had already been hospitalized with severe cases of COVID-19.
“It is a pill that it could treat patients at an early stage of their infection, making their recovery much easier and more effective. Too could prevent hospitals from overflowing, especially in places where vaccination rates are still low, such as many low- and lower-middle-income countries“said an investigation published in the scientific journal Nature.
During rehearsals, inclusion criteria required all patients to have laboratory-confirmed mild to moderate COVID-19, with onset of symptoms during the 5 days prior to the randomization of the study. All patients were required to have at least one risk factor when participating in the study.
Molnupiravir reduced the risk of hospitalization and / or death in all key subgroups; efficacy was not affected by timing of symptoms or underlying risk factor.
In addition, based on the participants with available viral sequencing data (approximately 40% of the participants), molnupiravir demonstrated consistent efficacy in the variants viral Gamma, Delta and Mu.
The international scientific community welcomes the appearance of new treatments to face the pandemic, although it is not yet clear whether molnupiravir will be accessible to everyone.
The United States has agreed buy 1.7 million courses of molnupiravir for $ 1.2 billion, which is equivalent to about $ 700 per treatment 5 days.
For its part, MSD has promised to make molnupiravir accessible worldwide and has already signed license agreements with five Indian companies that make generic drugs. Indian companies plan to price the drug at less than $ 12 per five-day treatment, according to recent reports.
MSD seeks produce 10 million treatments by the end of 2021, and it is expected that more doses will be produced in 2022, with agreements from different governments in order to lower the cost of the drug.
Because it is a pill, unlike the other monoclonal antibody treatments that are given intravenously, Molnupiravir is expected to become more widely used and hopefully reduce the death rate worldwide.