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WASHINGTON | The anti-COVID tablet developed by Merck is effective in the treatment of the virus, estimated the United States Medicines Agency (FDA) in a preliminary report published on Friday, however, recommending that it be excluded from use in pregnant women.
The publication comes ahead of a meeting of an FDA expert committee scheduled for November 30, where recommendations for emergency authorization of the drug, named molnupiravir , will be evaluated.
If approved, this drug would represent, according to experts, a major breakthrough in the fight against the pandemic by making it quite easy to reduce severe forms of the disease.
Merck released the full results of the test on Friday. clinical trial of the tablet, according to which the drug would reduce by 30% – well below the initial figure – the rate of hospitalization and death in patients at risk who took it soon after being infected.
In its report, the FDA considers molnupiravir effective in patients with COVID-19 and at risk of hospitalization.
However, it suggests that the committee not recommend the authorization of molnupiravir in patients pregnant women, believing that “there is no clinical scenario where the benefits outweigh the risks” in this population.
While no pregnant women were included in the Merck clinical trial, the FDA bases its recommendation on the results of the study in pregnant rats and rabbits, some litters of which had more malformation than in the breast. control groups.
For its authorization request, Merck relied on this clinical trial that it conducted with its partner Ridgeback Biotherapeutics on people with mild to moderate cases of COVID- 19 and at least one aggravating risk factor. They received treatment within five days of the first symptoms.
Merck first said the tablet, in a clinical trial, cut hospitalization and death rates in half, before revising that information down in Friday's full results.
< p> The interim results were seen after a study of just over 700 patients, half of whom received the tablet, the other half a placebo.
They were convincing enough that an independent committee Monitoring Committee, in consultation with the FDA, decides to stop the trial prematurely.
The full results come from analysis of more than 1,400 patients, leading to the more modest reduction in hospitalization and death rates.
The interim and full results both support “l 'efficacy and overall favorable benefit/risk assessment of molnupiravir' for the treatment of mild to moderate COVID-19 in high-risk adults, Merck said in a statement.
According to The full results, the hospitalization rate in patients who received the drug was 6.8%, compared to 9.7% in those who received placebo.
Death was observed in those who received the drug. people treated with molnupiravir, compared to 9 in the second group.
Antivirals like molnupiravir work by reducing a virus's ability to replicate, thereby slowing down disease.
Their application can be twofold: both to allow people already affected not to suffer from severe symptoms, but also to those who have been in close contact not to develop the disease.